505(b)(2) Drugs and HCPCS Codes

Updated weekly
Drugs listed
295
Pathway
FDA approval
Last updated
September 15, 2026
Source
FDA & CMS

505(b)(2) Pathway Explained

The 505(b)(2) drug approval pathway is a regulatory pathway in the United States, created by the Hatch-Waxman Amendments of 1984 and located under the Federal Food, Drug, and Cosmetic Act. It allows an abbreviated process for the approval of new drug applications (NDAs) that represent modifications to previously approved products.

During the approval process, the 505(b)(2) applicant can use the FDA's previous findings of safety and efficacy for an existing drug, while providing new data to support the changes made to the original product. This leads to a shorter and less costly development and approval process compared to a traditional NDA.

The three FDA approval pathways

The 505(b)(2) pathway is best understood next to the two it sits between: the full NDA for new drugs and the ANDA for generics.

Traditional NDA 505(b)(1) 505(b)(2) Hybrid ANDA 505(j)
Basis An entirely new drugA modification of an approved drugA generic copy of an approved drug
Clinical data required Full preclinical and clinical trialsExisting findings reused, plus new data for the changeBioequivalence to the reference drug
Development speed and cost Slowest, most expensiveFaster and less costly than an NDAFastest, lowest cost
HCPCS coding Its own HCPCS codeTypically its own unique HCPCS codeUsually shares an existing code

What qualifies for the 505(b)(2) pathway?

The pathway is uniquely suited to drugs that are neither completely new nor generic replicas. Qualifying products typically involve one of the following modifications to an already-approved drug.

  • New Formulation

    With preservative Preservative removed

    A manufacturer removes a preservative or chemical to create a similar but mildly different product.

  • New Dosage Form

    Tablet Liquid or extended-release

    A previously approved tablet is developed as a liquid or controlled-release version.

  • New Dosing Regimen

    Twice daily Once daily

    An approved twice-daily drug is reformulated to allow once-daily dosing.

  • New Route of Administration

    Oral Injectable

    A drug first approved as an oral product is later developed in an injectable form.

  • Combination Product

    Drug A + Drug B Single product

    Two or more previously approved drugs are combined into a single new product.

  • New Indication

    Depression Anxiety

    The same drug, first approved for one condition, is later found effective for another.

How 505(b)(2) impacts Buy and Bill

Since late 2022, a large wave of 505(b)(2) approvals has prompted CMS to grant HCPCS codes to many drugs that previously had none. That shift created several issues in the office-administered drug buy-and-bill process. A second wave is now arriving as ANDA generics reference those 505(b)(2) products as their RLD; see Generics Chasing 505(b)(2) Drugs for how the J-code lineage plays out.

  • Harder NDC–HCPCS mapping

    The surge of 505(b)(2) HCPCS codes has made NDC-to-HCPCS cross-walking far more complex. Many of these codes are not listed on the CMS HCPCS-NDC crosswalk file, leaving providers stranded.

  • Extreme ASP fluctuation

    New HCPCS codes for NDCs that were previously aligned to a single code can drive heavy quarter-to-quarter ASP price swings. BuyandBill.com provides accurate NDC-HCPCS alignments and ASP monitoring tools.

  • Diminishing role of NOC

    As 505(b)(2) HCPCS codes are implemented, CMS has begun clearing out the various NOC (Not Otherwise Classified) files published on its site.

Full 505(b)(2) drug list by HCPCS code

Below is our full list of 295 drugs approved or qualifying under the 505(b)(2) pathway, with their HCPCS codes. Manufacturer reflects who bills the code today, so a code billed by several companies is listed as a generic code rather than named to one of them. Search, sort, or export the list. Please note that it changes constantly and could contain errors.

HCPCS CodeHCPCS DescriptorIngredient NameManufacturer
J9153Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine(daunorubicin And Cytarabine) LiposomeJazz Pharmaceuticals
A9587Gallium ga-68, dotatate, diagnostic, 0.1 millicurie68ga-dotatateAdvanced Accelerator
J0131Injection, acetaminophen, not otherwise specified,10 mgAcetaminophenGeneric Code (Multiple Manufacturers)
J0134Injection, acetaminophen (fresenius kabi), not therapeutically equivalent to j0131, 10 mgAcetaminophenFresenius Kabi
J0136Injection, acetaminophen (b braun), not therapeutically equivalent to j0131, 10 mgAcetaminophenGeneric Code (Multiple Manufacturers)
J0137Injection, acetaminophen (hikma), not therapeutically equivalent to j0131, 10 mgAcetaminophenHikma
J0138Injection, acetaminophen 10 mg and ibuprofen 3 mgAcetaminophen And Ibuprofen InjectionHikma
J0216Injection, alfentanil hydrochloride, 500 microgramsAlfentanil HydrochlorideAkorn
J0206Injection, allopurinol sodium, 1 mgAllopurinol SodiumGeneric Code (Multiple Manufacturers)
J0281Injection, aminocaproic acid, 1 gramAminocaproic AcidGeneric Code (Multiple Manufacturers)
J0282Injection, amiodarone hydrochloride, 30 mgAmiodarone HydrochlorideGeneric Code (Multiple Manufacturers)
J0283Injection, amiodarone hydrochloride (nexterone), 30 mgAmiodarone HydrochlorideBaxter Healthcare
J0184Injection, amisulpride, 1 mgAmisulprideAcacia Pharma
J0185Injection, aprepitant, 1 mgAprepitantHeron Therapeutics
J8502Injection, aprepitant (aponvie), 1 mgAprepitantHeron Therapeutics
J0883Injection, argatroban, 1 mg (for non-esrd use)ArgatrobanGeneric Code (Multiple Manufacturers)
J0884Injection, argatroban, 1 mg (for esrd on dialysis)ArgatrobanGeneric Code (Multiple Manufacturers)
J0891Injection, argatroban (accord), not therapeutically equivalent to j0883, 1 mg (for non-esrd use)ArgatrobanAccord
J0892Injection, argatroban (accord), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)ArgatrobanAccord
J0898Injection, argatroban (auromedics), not therapeutically equivalent to j0883, 1 mg (for non-esrd use)ArgatrobanEugia US
J0899Injection, argatroban (auromedics), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)ArgatrobanEugia US
J1943Injection, aripiprazole lauroxil, (aristada initio), 1 mgAripiprazole LauroxilAlkermes
J1944Injection, aripiprazole lauroxil, (aristada), 1 mgAripiprazole LauroxilAlkermes
J0391Injection, artesunate, 1 mgArtesunateAmivas
J0461Injection, atropine sulfate, 0.01 mgAtropine SulfateGeneric Code (Multiple Manufacturers)
J0462Injection, atropine sulfate, not therapeutically equivalent to j0461, 0.01 mgAtropine SulfateGeneric Code (Multiple Manufacturers)
J0463Injection, atropine sulfate (fresenius and therapeutically equivalent), 0.01 mgAtropine SulfateGeneric Code (Multiple Manufacturers)
J9025Injection, azacitidine, 1 mgAzacitidineGeneric Code (Multiple Manufacturers)
J0457Injection, aztreonam, 100 mgAztreonamGeneric Code (Multiple Manufacturers)
J0458Injection, aztreonam/avibactam, 7.5 mg/2.5 mg (10 mg)AztreonamAbbvie
J9033Injection, bendamustine hydrochloride, not otherwise specified, 1 mgBendamustine HydrochlorideGeneric Code (Multiple Manufacturers)
J9034Injection, bendamustine hcl (bendeka), 1 mgBendamustine HydrochlorideTeva
J9036Injection, bendamustine hydrochloride, (belrapzo/bendamustine), 1 mgBendamustine HydrochlorideGeneric Code (Multiple Manufacturers)
J9056Injection, bendamustine hydrochloride (vivimusta), 1 mgBendamustine HydrochlorideGeneric Code (Multiple Manufacturers)
J0582Injection, bivalirudin (endo), not therapeutically equivalent to j0583, 1 mgBivalirudinPar Pharmaceutical, Inc
J0583Injection, bivalirudin, 1 mgBivalirudinGeneric Code (Multiple Manufacturers)
J9041Injection, bortezomib, 0.1 mgBortezomibGeneric Code (Multiple Manufacturers)
J9046Injection, bortezomib (dr. reddy's), not therapeutically equivalent to j9041, 0.1 mgBortezomibDr Reddy's Laboratories, Inc
J9048Injection, bortezomib (fresenius kabi), not therapeutically equivalent to j9041, 0.1 mgBortezomibFresenius Kabi
J9049Injection, bortezomib (hospira), not therapeutically equivalent to j9041, 0.1 mgBortezomibHospira
J9051Injection, bortezomib (maia), not therapeutically equivalent to j9041, 0.1 mgBortezomibFosun Pharma
J9054Injection, bortezomib (boruzu), 0.1 mgBortezomibAmneal Biosciences
J1939Injection, bumetanide, 0.5 mgBumetanideGeneric Code (Multiple Manufacturers)
J0666Injection, bupivacaine liposome, 1 mgBupivacainePacira Pharmaceuticals
J0668Instillation, bupivacaine and meloxicam, 1 mg/0.03 mgBupivacaine And MeloxicamHeron Therapeutics
J0665Injection, bupivicaine, not otherwise specified, 0.5 mgBupivicaineGeneric Code (Multiple Manufacturers)
J0577Injection, buprenorphine extended-release (brixadi), less than or equal to 7 days of therapyBuprenorphine Extended-releaseBraeburn Pharmaceutical
J0578Injection, buprenorphine extended release (brixadi), greater than 7 days and up to 28 days of therapyBuprenorphine Extended-releaseBraeburn Pharmaceutical
Q9991Injection, buprenorphine extended-release (sublocade), less than or equal to 100 mgBuprenorphine Extended-releaseIndivior
Q9992Injection, buprenorphine extended-release (sublocade), greater than 100 mgBuprenorphine Extended-releaseIndivior
J9043Injection, cabazitaxel, 1 mgCabazitaxelSanofi
J0612Injection, calcium gluconate, not otherwise specified, 10 mgCalcium GluconateGeneric Code (Multiple Manufacturers)
J0613Injection, calcium gluconate (wg critical care), not therapeutically equivalent to j0612, 10 mgCalcium GluconateWg Critical Care
J7340Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100 mlCarbidopa And LevodopaAbbvie
J9278Injection, carboplatin (avyxa), 1 mgCarboplatinAvyxa Pharma
J0675Injection, carboprost tromethamine, 0.1 mgCarboprost TromethamineGeneric Code (Multiple Manufacturers)
J9050Injection, carmustine, 100 mgCarmustineGeneric Code (Multiple Manufacturers)
J9052Injection, carmustine (accord), not therapeutically equivalent to j9050, 100 mgCarmustineAccord
J0637Injection, caspofungin acetate, 5 mgCaspofungin AcetateGeneric Code (Multiple Manufacturers)
J0687Injection, cefazolin sodium (wg critical care), not therapeutically equivalent to j0690, 500 mgCefazolin SodiumWg Critical Care
J0688Injection, cefazolin sodium (hikma), not therapeutically equivalent to j0690, 500 mgCefazolin SodiumHikma
J0689Injection, cefazolin sodium (baxter), not therapeutically equivalent to j0690, 500 mgCefazolin SodiumBaxter Healthcare
J0690Injection, cefazolin sodium, 500 mgCefazolin SodiumGeneric Code (Multiple Manufacturers)
J0692Injection, cefepime hydrochloride, 500 mgCefepime HydrochlorideGeneric Code (Multiple Manufacturers)
J0701Injection, cefepime hydrochloride (baxter), not therapeutically equivalent to maxipime, 500 mgCefepime HydrochlorideBaxter Healthcare
J0703Injection, cefepime hydrochloride (b braun), not therapeutically equivalent to maxipime, 500 mgCefepime HydrochlorideB. Braun Medical Inc
J0525Injection, cefotetan disodium, 10 mgCefotetan SodiumGeneric Code (Multiple Manufacturers)
J0714Injection, ceftazidime and avibactam, 0.5 g/0.125 gCeftazidime, AvibactamAllergan
J1201Injection, cetirizine hydrochloride, 0.5 mgCetirizine HydrochlorideGeneric Code (Multiple Manufacturers)
J2401Injection, chloroprocaine hydrochloride, per 1 mgChloroprocaine HydrochlorideGeneric Code (Multiple Manufacturers)
J2402Injection, chloroprocaine hydrochloride (clorotekal), per 1 mgChloroprocaine HydrochlorideB. Braun Medical Inc
J2403Chloroprocaine hcl ophthalmic, 3% gel, 1 mgChloroprocaine HydrochlorideHarrow Eye
J0759Injection, clevidipine butyrate, 1 mgClevidipine ButyrateChiesi USA
J0736Injection, clindamycin phosphate, 300 mgClindamycin PhosphateGeneric Code (Multiple Manufacturers)
J0737Injection, clindamycin phosphate (baxter), not therapeutically equivalent to j0736, 300 mgClindamycin PhosphateBaxter Healthcare
J7213Injection, coagulation factor ix (recombinant), ixinity, 1 i.u.Coagulation Factor IxGeneric Code (Multiple Manufacturers)
C9046Cocaine hydrochloride nasal solution (goprelto), 1 mgCocaine HydrochlorideGenus Lifesciences
J0014Cocaine HydrochlorideLxo Us
C9143Cocaine hydrochloride nasal solution (numbrino), 1 mgCocaine Hydrochloride NasalOmnivium Pharmaceuticals
J7299Intrauterine copper contraceptive (miudella)CopperOrganon
A9592Copper cu-64, dotatate, diagnostic, 1 millicurieCopper Cu 64 DotatateCurium US
J9071Injection, cyclophosphamide (auromedics), 5 mgCyclophosphamideEugia US
J9072Injection, cyclophosphamide (frindovyx), 5 mgCyclophosphamideAvyxa Pharma
J9073Injection, cyclophosphamide (dr. reddy's), 5 mgCyclophosphamideGeneric Code (Multiple Manufacturers)
J9074Injection, cyclophosphamide (sandoz), 5 mgCyclophosphamideSandoz
J9075Injection, cyclophosphamide, not otherwise specified, 5 mgCyclophosphamideGeneric Code (Multiple Manufacturers)
J9076Injection, cyclophosphamide (baxter), 5 mgCyclophosphamideBaxter Healthcare
J0871Injection, daptomycin (endo), not therapeutically equivalent to j0878, 1 mgDaptomycinPar Pharmaceutical, Inc
J0872Injection, daptomycin (xellia), unrefrigerated, not therapeutically equivalent to j0878 or j0873, 1 mgDaptomycinGeneric Code (Multiple Manufacturers)
J0873Injection, daptomycin (xellia), not therapeutically equivalent to j0878 or j0872, 1 mgDaptomycinGeneric Code (Multiple Manufacturers)
J0874Injection, daptomycin (baxter), not therapeutically equivalent to j0878, 1 mgDaptomycinBaxter Healthcare
J0877Injection, daptomycin (hospira), not therapeutically equivalent to j0878, 1 mgDaptomycinGeneric Code (Multiple Manufacturers)
J0878Injection, daptomycin, 1 mgDaptomycinGeneric Code (Multiple Manufacturers)
J0893Injection, decitabine (sun pharma), not therapeutically equivalent to j0894, 1 mgDecitabineSun Pharma
J0894Injection, decitabine, 1 mgDecitabineGeneric Code (Multiple Manufacturers)
J1095Injection, dexamethasone 9 percent, intraocular, 1 microgramDexamethasoneEyePoint Pharmaceuticals US
J1096Dexamethasone, lacrimal ophthalmic insert, 0.1 mgDexamethasoneOcular Therapeutix
J8541Dexamethasone (hemady), oral, 0.25 mgDexamethasoneGeneric Code (Multiple Manufacturers)
J1105Dexmedetomidine, oral, 1 mcgDexmedetomidineBioXcel Therapeutics
J1164Injection, diltiazem hydrochloride in 0.72% sodium chloride, 0.5 mgDiltiazemWg Critical Care
J9171Injection, docetaxel, 1 mgDocetaxelGeneric Code (Multiple Manufacturers)
J9172Injection, docetaxel (docivyx), 1 mgDocetaxelAvyxa Pharma
J9174Injection, docetaxel (beizray), 1 mgDocetaxelZydus Pharmaceuticals
J1271Injection, doxycycline hyclate, 1 mgDoxycycline HyclateGeneric Code (Multiple Manufacturers)
Q0155Dronabinol (syndros), 0.1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimenDronabinolBenuvia Therapeutics
J3387Injection, elivaldogene autotemcel, per treatmentElivaldogeneGenetix Biotherapeutics
J0162Injection, epinephrine (fresenius), not therapeutically equivalent to j0165, 0.1 mgEpinephrineFresenius Kabi
J0163Injection, epinephrine in sodium chloride (endo), 0.1 mgEpinephrinePar Pharmaceutical, Inc
J0164Injection, epinephrine in sodium chloride (baxter), 0.1 mgEpinephrineBaxter Healthcare
J0165Injection, epinephrine, not otherwise specified, 0.1 mgEpinephrineGeneric Code (Multiple Manufacturers)
J0166Injection, epinephrine (bpi), not therapeutically equivalent to j0165, 0.1 mgEpinephrineGeneric Code (Multiple Manufacturers)
J0167Injection, epinephrine (hospira), not therapeutically equivalent to j0165, 0.1 mgEpinephrinePfizer
J0168Injection, epinephrine (international medication systems), not therapeutically equivalent to j0165, 0.1 mgEpinephrineGeneric Code (Multiple Manufacturers)
J0169Injection, epinephrine (adrenalin), not therapeutically equivalent to j0165, 0.1 mgEpinephrinePar Pharmaceutical, Inc
J0013Esketamine, nasal spray, 1 mgEsketamineJanssen
J1805Injection, esmolol hydrochloride, 10 mgEsmolol HydrochlorideGeneric Code (Multiple Manufacturers)
J1806Injection, esmolol hydrochloride (wg critical care), not therapeutically equivalent to j1805, 10 mgEsmolol HydrochlorideWg Critical Care
J1370Injection, esomeprazole sodium, 1 mgEsomeprazole SodiumGeneric Code (Multiple Manufacturers)
J9186Injection, etoposide (avyxa), 1 mgEtoposideAvyxa Pharma
J1308Injection, famotidine, 0.25 mgFamotidineGeneric Code (Multiple Manufacturers)
J7174Injection, fitusiran, 0.04 mgFitusiranGenzyme
A9602Fluorodopa f-18, diagnostic, per millicurieFluorodopa F18The Feinstein Institute for Medical Research
A9591Fluoroestradiol f 18, diagnostic, 1 millicurieFluoroestradiol F 18Ge Healthcare
J9191Injection, fluorouracil (avyxa), 10 mgFluorouracilAvyxa Pharma
J1808Injection, folic acid, 0.1 mgFolic AcidGeneric Code (Multiple Manufacturers)
J1434Injection, fosaprepitant (focinvez), 1 mgFosaprepitantAmneal Biosciences
J1453Injection, fosaprepitant, 1 mgFosaprepitantGeneric Code (Multiple Manufacturers)
J1456Injection, fosaprepitant (teva), not therapeutically equivalent to j1453, 1 mgFosaprepitantActavis Pharma
J7356Injection, foscarbidopa 0.25 mg/foslevodopa 5 mgFoscarbidopa/foslevodopaAbbvie
J0528Injection, fosfomycin disodium, 20 mgFosfomycin DisodiumMeitheal Pharmaceuticals Inc
J9393Injection, fulvestrant (teva), not therapeutically equivalent to j9395, 25 mgFulvestrantAvyxa Pharma
J9394Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mgFulvestrantFresenius Kabi
J9395Injection, fulvestrant, 25 mgFulvestrantGeneric Code (Multiple Manufacturers)
J1938Injection, furosemide, 1 mgFurosemideGeneric Code (Multiple Manufacturers)
J1941Injection, furosemide (furoscix), 20 mgFurosemideScpharmaceuticals
J1947Injection, furosemide (furoscix), 1 mgFurosemide Injection 80 Mg/ 10 MlScpharmaceuticals
J1570Injection, ganciclovir sodium, 500 mgGanciclovir SodiumGeneric Code (Multiple Manufacturers)
J1574Injection, ganciclovir sodium (exela), not therapeutically equivalent to j1570, 500 mgGanciclovir SodiumExela Pharma Sciences
J9184Injection, gemcitabine hydrochloride (avyxa), 200 mgGemcitabineAvyxa Pharma
J9196Injection, gemcitabine hydrochloride (accord), not therapeutically equivalent to j9201, 200 mgGemcitabineAccord
J9198Injection, gemcitabine hydrochloride, (infugem), 100 mgGemcitabineSun Pharma
J9201Injection, gemcitabine hydrochloride, not otherwise specified, 200 mgGemcitabineGeneric Code (Multiple Manufacturers)
J9183Gemcitabine intravesical system, 225 mgGemcitabine IntravesicalJanssen
J1610Injection, glucagon hydrochloride, per 1 mgGlucagon HydrochlorideGeneric Code (Multiple Manufacturers)
J1611Injection, glucagon hydrochloride (fresenius kabi), not therapeutically equivalent to j1610, per 1 mgGlucagon HydrochlorideFresenius Kabi
J1612Injection, glucagon (gvoke), 0.01 mgGlucagon HydrochlorideGeneric Code (Multiple Manufacturers)
J1596Injection, glycopyrrolate, 0.1 mgGlycopyrrolateGeneric Code (Multiple Manufacturers)
J1597Injection, glycopyrrolate (glyrx-pf), 0.1 mgGlycopyrrolateExela Pharma Sciences
J1598Injection, glycopyrrolate (fresenius kabi), not therapeutically equivalent to j1596, 0.1 mgGlycopyrrolateFresenius Kabi
A9596Gallium ga-68 gozetotide, diagnostic, (illuccix), 1 millicurieGozetotideTelix Pharmaceuticals US
A9616Gallium ga-68 gozetotide (gozellix), diagnostic, 1 millicurieGozetotideTelix Pharmaceuticals US
J1627Injection, granisetron, extended-release, 0.1 mgGranisetronHeron Therapeutics
J1642Injection, heparin sodium, (heparin lock flush), per 10 unitsHeparin SodiumGeneric Code (Multiple Manufacturers)
J1643Injection, heparin sodium (pfizer), not therapeutically equivalent to j1644, per 1000 unitsHeparin SodiumPfizer
J1644Injection, heparin sodium, per 1000 unitsHeparin SodiumGeneric Code (Multiple Manufacturers)
J1171Injection, hydromorphone, 0.1 mgHydromorphone HydrochlorideGeneric Code (Multiple Manufacturers)
J3424Injection, hydroxocobalamin, intravenous, 25 mgHydroxocobalaminGeneric Code (Multiple Manufacturers)
J3425Injection, hydroxocobalamin, intramuscular, 10 mcgHydroxocobalaminActavis Pharma
J1749Injection, iloprost, 0.1 mcgIloprostBTG International
J1552Injection, immune globulin (alyglo), 500 mgImmune GlobulinGC Biopharma
J1566Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mgImmune GlobulinTakeda Pharmaceuticals
J1576Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mgImmune GlobulinGeneric Code (Multiple Manufacturers)
J9220Injection, indigotindisulfonate sodium, 1 mgIndigotindisulfonate SodiumGeneric Code (Multiple Manufacturers)
J1811Insulin (fiasp) for administration through dme (i.e., insulin pump) per 50 unitsInsulinNovo Nordisk
J1812Insulin (fiasp), per 5 unitsInsulinNovo Nordisk
J1813Insulin (lyumjev) for administration through dme (i.e., insulin pump) per 50 unitsInsulinGeneric Code (Multiple Manufacturers)
J1814Insulin (lyumjev), per 5 unitsInsulinEli Lilly
J9205Injection, irinotecan liposome, 1 mgIrinotecan HydrochlorideIpsen Biopharma
Q9968Injection, non-radioactive, non-contrast, visualization adjunct (e.g., methylene blue, isosulfan blue), 1 mgIsosulfan BlueGeneric Code (Multiple Manufacturers)
A9800Gallium ga-68 gozetotide, diagnostic, (locametz), 1 millicurieKit For The Preparation Of Gallium Ga 68 GozetotideGeneric Code (Multiple Manufacturers)
J1920Injection, labetalol hydrochloride, 5 mgLabetalol HydrochlorideGeneric Code (Multiple Manufacturers)
J1921Injection, labetalol hydrochloride (hikma), not therapeutically equivalent to j1920, 5 mgLabetalol HydrochlorideHikma
J1932Injection, lanreotide, (cipla), 1 mgLanreotide AcetateCipla USA
C9310Injection, leucovorin calcium (avyxa), 1 mgLeucovorin CalciumAvyxa Pharma
J0644Injection, leucovorin calcium (avyxa), 1 mgLeucovorin CalciumAvyxa Pharma
J1950Injection, leuprolide acetate (for depot suspension), per 3.75 mgLeuprolide AcetateAbbvie
J1951Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mgLeuprolide AcetateTolmar Pharmaceuticals, Inc
J1952Leuprolide injectable, camcevi, 1 mgLeuprolide AcetateAccord
J1954Injection, leuprolide acetate for depot suspension (lutrate depot), 7.5 mgLeuprolide AcetateGeneric Code (Multiple Manufacturers)
J9217Leuprolide acetate (for depot suspension), 7.5 mgLeuprolide AcetateGeneric Code (Multiple Manufacturers)
J0642Injection, levoleucovorin (khapzory), 0.5 mgLevoleucovorinAcrotech Biopharma
J7297Levonorgestrel-releasing intrauterine contraceptive system (liletta), 52 mgLevonorgestrelAllergan
J0650Injection, levothyroxine sodium, not otherwise specified, 10 mcgLevothyroxine SodiumGeneric Code (Multiple Manufacturers)
J0651Injection, levothyroxine sodium (fresenius kabi), not therapeutically equivalent to j0650, 10 mcgLevothyroxine SodiumFresenius Kabi
J0652Injection, levothyroxine sodium (hikma), not therapeutically equivalent to j0650, 10 mcgLevothyroxine SodiumHikma
J2020Injection, linezolid, 200 mgLinezolidGeneric Code (Multiple Manufacturers)
J2021Injection, linezolid (hospira), not therapeutically equivalent to j2020, 200 mgLinezolidGeneric Code (Multiple Manufacturers)
J0654Injection, liothyronine, 1 mcgLiothyronineXGen Pharmaceuticals DJB, Inc
J2151Injection, mannitol, 250 mgMannitolGeneric Code (Multiple Manufacturers)
J1737Injection, meloxicam (azurity), 1 mgMeloxicamAzurity Pharmaceuticals Inc
J1738Injection, meloxicam, 1 mgMeloxicamBaudax Bio
J9246Injection, melphalan (evomela), 1 mgMelphalanAcrotech Biopharma
J9249Injection, melphalan (apotex), 1 mgMelphalan HclApotex
J9248Injection, melphalan (hepzato), 1 mgMelphalan Hydrochloride Injection, Powder, Lyophilized, For SolutionDelcath Systems
J2183Injection, meropenem (wg critical care), not therapeutically equivalent to j2185, 100 mgMeropenemGeneric Code (Multiple Manufacturers)
J2184Injection, meropenem (b. braun), not therapeutically equivalent to j2185, 100 mgMeropenemB. Braun Medical Inc
J2185Injection, meropenem, 100 mgMeropenemGeneric Code (Multiple Manufacturers)
J8610Methotrexate; oral, 2.5 mgMethotrexateGeneric Code (Multiple Manufacturers)
J8611Methotrexate (jylamvo), oral, 2.5 mgMethotrexateShorla Oncology
J8612Methotrexate (xatmep), oral, 2.5 mgMethotrexateAzurity Pharmaceuticals Inc
J1010Injection, methylprednisolone acetate, 1 mgMethylprednisolone AcetateGeneric Code (Multiple Manufacturers)
J2919Injection, methylprednisolone sodium succinate, 5 mgMethylprednisolone Sodium SuccinateGeneric Code (Multiple Manufacturers)
J1836Injection, metronidazole, 10 mgMetronidazoleGeneric Code (Multiple Manufacturers)
J2246Injection, micafungin in sodium (baxter), not therapeutically equivalent to j2248, 1 mgMicafungin SodiumBaxter Healthcare
J2247Injection, micafungin sodium (par pharm) not thereapeutically equivalent to j2248, 1 mgMicafungin SodiumGeneric Code (Multiple Manufacturers)
J2248Injection, micafungin sodium, 1 mgMicafungin SodiumGeneric Code (Multiple Manufacturers)
J2250Injection, midazolam hydrochloride, per 1 mgMidazolam HydrochlorideGeneric Code (Multiple Manufacturers)
J2251Injection, midazolam in 0.9% sodium chloride, intravenous, not therapeutically equivalent to j2250, 1 mgMidazolam HydrochlorideGeneric Code (Multiple Manufacturers)
J2252Injection, midazolam in 0.8% sodium chloride, intravenous, not therapeutically equivalent to j2250, 1 mgMidazolam HydrochlorideGeneric Code (Multiple Manufacturers)
J1202Miglustat, oral, 65 mgMiglustatAmicus Therapeutics
J9281Mitomycin pyelocalyceal instillation, 1 mgMitomycinUroGen Pharma
J9282Mitomycin, intravesical instillation, 1 mgMitomycinUroGen Pharma
J7402Mometasone furoate sinus implant, (sinuva), 10 microgramsMometasone FuroateIntersect Ent
J2270Injection, morphine sulfate, up to 10 mgMorphine SulfateGeneric Code (Multiple Manufacturers)
J2272Injection, morphine sulfate (fresenius kabi), not therapeutically equivalent to j2270, up to 10 mgMorphine SulfateFresenius Kabi
J2274Injection, morphine sulfate, preservative-free for epidural or intrathecal use, 10 mgMorphine SulfateGeneric Code (Multiple Manufacturers)
J2280Injection, moxifloxacin, 100 mgMoxifloxacinMylan Pharmaceuticals
J2281Injection, moxifloxacin (fresenius kabi), not therapeutically equivalent to j2280, 100 mgMoxifloxacinFresenius Kabi
J7514Mycophenolate mofetil (myhibbin), oral suspension, 100 mgMycophenolate MofetilAzurity Pharmaceuticals Inc
J7519Injection, mycophenolate mofetil, 10 mgMycophenolate MofetilGeneric Code (Multiple Manufacturers)
J7528Mycophenolate mofetil, for suspension, oral, 100 mgMycophenolate MofetilGeneric Code (Multiple Manufacturers)
J7530Mycophenolate mofetil (myhibbin), oral suspension, 5 mgMycophenolate MofetilAzurity Pharmaceuticals Inc
J2290Injection, nafcillin sodium, 20 mgNafcillin SodiumGeneric Code (Multiple Manufacturers)
J2291Injection, nafcillin sodium (baxter), 20 mgNafcillin SodiumBaxter Healthcare
J2312Injection, naloxone hydrochloride, not otherwise specified, 0.01 mgNaloxone HydrochlorideGeneric Code (Multiple Manufacturers)
J2313Injection, naloxone hydrochloride (zimhi), 0.01 mgNaloxone HydrochlorideUs Worldmeds
J2710Injection, neostigmine methylsulfate, up to 0.5 mgNeostigmine MethylsulfateGeneric Code (Multiple Manufacturers)
J2711Injection, neostigmine methylsulfate 0.1 mg and glycopyrrolate 0.02 mgNeostigmine MethylsulfateGeneric Code (Multiple Manufacturers)
J2404Injection, nicardipine, 0.1 mgNicardipineGeneric Code (Multiple Manufacturers)
J2305Injection, nitroglycerin, 5 mgNitroglycerinGeneric Code (Multiple Manufacturers)
J7304Contraceptive supply, hormone containing patch, eachNorelgestromin And Ethinyl EstradiolGeneric Code (Multiple Manufacturers)
J2359Injection, olanzapine, 0.5 mgOlanzapineGeneric Code (Multiple Manufacturers)
J9264Injection, paclitaxel protein-bound particles, 1 mgPaclitaxelGeneric Code (Multiple Manufacturers)
J9267Injection, paclitaxel, 1 mgPaclitaxelGeneric Code (Multiple Manufacturers)
J2426Injection, paliperidone palmitate extended release (invega sustenna), 1 mgPaliperidone Palmitate Extended ReleaseJanssen
J2428Injection, paliperidone palmitate extended release (erzofri), 1 mgPaliperidone Palmitate Extended ReleaseShandong Luye Pharmaceuticals
J2468Injection, palonosetron hydrochloride (posfrea), 25 microgramsPalonosetron HCLAvyxa Pharma
J2469Injection, palonosetron hcl, 25 mcgPalonosetron HydrochlorideGeneric Code (Multiple Manufacturers)
J2470Injection, pantoprazole sodium, 40 mgPantoprazole SodiumGeneric Code (Multiple Manufacturers)
J2471Injection, pantoprazole (hikma), not therapeutically equivalent to j2470, 40 mgPantoprazole SodiumGeneric Code (Multiple Manufacturers)
J2472Injection, pantoprazole sodium in sodium chloride (baxter), 40 mgPantoprazole SodiumBaxter Healthcare
J2501Injection, paricalcitol, 1 mcgParicalcitolGeneric Code (Multiple Manufacturers)
J9292Injection, pemetrexed dipotassium, 10 mgPemetrexedAvyxa Pharma
J9294Injection, pemetrexed (hospira), not therapeutically equivalent to j9305, 10 mgPemetrexedHospira
J9296Injection, pemetrexed (accord), not therapeutically equivalent to j9305, 10 mgPemetrexedAccord
J9297Injection, pemetrexed (sandoz), not therapeutically equivalent to j9305, 10 mgPemetrexedSandoz
J9304Injection, pemetrexed (pemfexy), 10 mgPemetrexedGeneric Code (Multiple Manufacturers)
J9305Injection, pemetrexed, not otherwise specified, 10 mgPemetrexedGeneric Code (Multiple Manufacturers)
J9314Injection, pemetrexed (teva), not therapeutically equivalent to j9305, 10 mgPemetrexedTeva
J9322Injection, pemetrexed (bluepoint), not therapeutically equivalent to j9305, 10 mgPemetrexedBluepoint Laboratories
J9323Injection, pemetrexed ditromethamine, 10 mgPemetrexedPfizer
J9324Injection, pemetrexed (pemrydi rtu), 10 mgPemetrexedAmneal Biosciences
J2516Injection, pentamidine isethionate, 1 mgPentamidine IsethionateGeneric Code (Multiple Manufacturers)
J2560Injection, phenobarbital sodium, up to 120 mgPhenobarbital SodiumGeneric Code (Multiple Manufacturers)
J2561Injection, phenobarbital sodium (sezaby), 1 mgPhenobarbital SodiumSun Pharma
J2371Injection, phenylephrine hydrochloride, 20 microgramsPhenylephrine HydrochlorideGeneric Code (Multiple Manufacturers)
J2372Injection, phenylephrine hydrochloride (biorphen), 20 microgramsPhenylephrine HydrochlorideGeneric Code (Multiple Manufacturers)
J2373Injection, phenylephrine hydrochloride (immphentiv), 20 microgramsPhenylephrine HydrochlorideHikma
A9595Piflufolastat f 18 (pylarify), diagnostic, 1 millicuriePiflufolastat F-18Progenics Pharmaceuticals, Inc
J2543Injection, piperacillin sodium/tazobactam sodium, 1 gram/0.125 grams (1.125 grams)Piperacillin And TazobactamGeneric Code (Multiple Manufacturers)
J1837Injection, posaconazole, 1 mgPosaconazoleGeneric Code (Multiple Manufacturers)
J2787Riboflavin 5'-phosphate, ophthalmic solution (photrexa viscous/photrexa), up to 3 mlRiboflavin 5-phosphate OphthalmicGlaukos
J2789Riboflavin 5'-phosphate, ophthalmic solution (epioxahd/epioxa), up to 2 mlRiboflavin 5-phosphate OphthalmicGlaukos
J2804Injection, rifampin, 1 mgRifampinGeneric Code (Multiple Manufacturers)
J2794Injection, risperidone (risperdal consta), 0.5 mgRisperidoneGeneric Code (Multiple Manufacturers)
J2798Injection, risperidone, (perseris), 0.5 mgRisperidoneIndivior
J2799Injection, risperidone (uzedy), 1 mgRisperidoneTeva
J2801Injection, risperidone (rykindo), 0.5 mgRisperidoneShandong Luye Pharmaceuticals
J2805Injection, sincalide, 5 microgramsSincalideGeneric Code (Multiple Manufacturers)
J9331Injection, sirolimus protein-bound particles, 1 mgSirolimusAadi Bioscience
J0208Injection, sodium thiosulfate (pedmark), 100 mgSodium ThiosulfateFennec Pharmaceuticals
J2865Injection, sulfamethoxazole 5 mg and trimethoprim 1 mgSulfamethoxazole And TrimethoprimGeneric Code (Multiple Manufacturers)
J3030Injection, sumatriptan succinate, 6 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)Sumatriptan SuccinateGeneric Code (Multiple Manufacturers)
J3110Injection, teriparatide, 10 mcgTeriparatideGeneric Code (Multiple Manufacturers)
J1072Injection, testosterone cypionate (azmiro), 1 mgTestosterone CypionateAzurity Pharmaceuticals Inc
J3121Injection, testosterone enanthate, 1 mgTestosterone EnanthateGeneric Code (Multiple Manufacturers)
J9341Injection, thiotepa (tepylute), 1 mgThiotepaShorla Oncology
J9342Injection, thiotepa, not otherwise specified, 1 mgThiotepaGeneric Code (Multiple Manufacturers)
J3243Injection, tigecycline, 1 mgTigecyclineGeneric Code (Multiple Manufacturers)
J3244Injection, tigecycline (accord), not therapeutically equivalent to j3243, 1 mgTigecyclineAccord
J3290Injection, tranexamic acid, 5 mgTranexamic AcidGeneric Code (Multiple Manufacturers)
J3291Injection, tranexamic acid in sodium chloride, 5 mgTranexamic AcidExela Pharma Sciences
J7355Injection, travoprost, intracameral implant, 1 microgramTravoprost IntracameralGlaukos
J3299Injection, triamcinolone acetonide (xipere), 1 mgTriamcinolone AcetonideBausch Health
J3304Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mgTriamcinolone Acetonide Extended-release Injectable SuspensionPacira Pharmaceuticals
J2186Injection, meropenem and vaborbactam, 10mg/10mg (20mg)VabomereMelinta Therapeutics
J3373Injection, vancomycin hydrochloride, 10 mgVancomycin HclGeneric Code (Multiple Manufacturers)
J3374Injection, vancomycin hydrochloride (mylan) not therapeutically equivalent to j3373, 10 mgVancomycin HclGeneric Code (Multiple Manufacturers)
J3375Injection, vancomycin hydrochloride (tyzavan), not therapeutically equivalent to j3373, 10 mgVancomycin HclGeneric Code (Multiple Manufacturers)
J3376Injection, vancomycin hcl (hikma), not therapeutically equivalent to j3373, 10 mgVancomycin HclHikma
J2596Injection, vasopressin (long grove), not therapeutically equivalent to j2598, 1 unitVasopressinLong Grove Pharmaceuticals
J2598Injection, vasopressin, 1 unitVasopressinGeneric Code (Multiple Manufacturers)
J2599Injection, vasopressin (american regent), not therapeutically equivalent to j2598, 1 unitVasopressinGeneric Code (Multiple Manufacturers)
J2601Injection, vasopressin (baxter), 1 unitVasopressin In 0.9% Sodium ChlorideBaxter Healthcare
J3465Injection, voriconazole, 10 mgVoriconazoleGeneric Code (Multiple Manufacturers)

Frequently asked questions

What is a 505(b)(2) drug?

A 505(b)(2) drug is approved through an abbreviated FDA pathway designed for modifications of already-approved products, such as a new formulation, dosage form, route of administration, or indication. 505(b)(2) products qualify for their own unique J-codes and are not grouped into generic codes.

How is 505(b)(2) different from an NDA and an ANDA?

A traditional NDA is for entirely new drugs and requires full clinical trials. An ANDA is the generic pathway and relies on proving bioequivalence to the reference drug. 505(b)(2) sits between the two: it reuses existing findings like an ANDA but supports a genuine modification like an NDA.

Why does a 505(b)(2) drug get its own HCPCS code?

Because a 505(b)(2) product is a distinct drug rather than a generic equivalent, CMS typically assigns it its own unique HCPCS J-code instead of grouping it under an existing code.

See the latest HCPCS code approvals →

How does the 505(b)(2) surge affect ASP pricing?

When NDCs that once shared a single HCPCS code are split across new 505(b)(2) HCPCS J-codes, they each receive their own average sales price (ASP). This can cause ASPs tied to each J-code to swing sharply from quarter to quarter.

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