505(b)(2) Drugs and HCPCS Codes

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. The 505(b)(2) pathway allows for an abbreviated process for the approval of new drug applications (NDAs) that represent modifications to previously approved products. Below is a breakdown of the 505(b)(2) pathway compared to other prominent approval drug pathways:

505(b)(2) Pathway:

The 505(b)(2) approval process is designed for drugs that represent modifications of previously approved products. These modifications could include:

  • New Formulation
  • New Dosage Form
  • New Dosing Regime
  • New Route of Administration
  • Combination Product
  • New Indication for an Existing Product

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/approval process compared to a traditional NDA.

Traditional NDA (New Drug Application):

The traditional NDA, also known as the 505(b)(1) pathway is the standard approval pathway for entirely new drugs. The NDA requires extensive data from preclinical and clinical studies from the applicant in order demonstrate the safety and efficacy of the drug. Earning drug approval under the traditional NDA is a time-consuming and often very expensive process.

ANDA (Abbreviated New Drug Application) for Generics:

An ANDA, also known as the 505(j) pathway exists for generic version of previously-approved brand name drugs. Rather than demonstrating safety and efficacy through new clinical trials, the generic drug manufacturer must demonstrate bioequivalence to the reference listed drug (RLD). In other words, that the drug is the same in terms of quality, performance, and intended use. The provides a timely and efficient manner for generic drugs to gain approval and enter the market.

The 505(b)(2) pathway provides an intriguing option for manufacturers seeking a hybrid between the traditional NDA process and the ANDA for generic products.

What Types of Drugs Qualify for the 505(b)(2) Pathway?

The 505(b)(2) pathway is uniquely suited for drugs that aren’t completely new (which would generally go through the traditional NDA process) and aren’t generic replicas (which would go through the ANDA process). As explained previously, drugs that qualify for 505(b)(2) might involve changes in dosage form, strength, formulation, administration route, or indication. To delve a bit deeper into the modifications that might warrant a 505(b)(2) approval:

  • New Formulation: If a manufacturer removed a certain preservative or chemical from a drug, to create a similar but mildly-different product.
  • New Dosage Form: If a previously approved drug was in tablet form, and another company develops a liquid formulation or a controlled-release version.
  • New Dosing Regimen: If an approved drug is taken twice daily, and a new formulation allows for once-daily dosing.
  • New Route of Administration: If a drug was initially approved as an oral drug, and another company later develops an injectable form.
  • Combination Product: A manufacturer combines two or more previously approved drugs into a single new product.
  • New Indication for an Existing Product: If a drug was initially approved for depression and later is found to be effective for anxiety.

How Does the Current Application of 505(b)(2) impact Buy and Bill?

In the year of 2023, there has been a tremendous wave of new 505(b)(2) pathway drug approvals. Although 505(b)(2) has existed since 1984, it was not actively enforced and perpetuated by the Centers for Medicare & Medicaid Services until late 2022/early 2023.

During this period of time, the Centers for Medicare & Medicaid Services along with various pharma manufacturers have actively worked to achieve 505(b)(2) approvals and enforce 505(b)(2) status to certain drugs. More specifically, CMS has granted HCPCS codes to a very large number of drugs that had previously been approved under the 505(b)(2) pathway or qualified for 505(b)(2) status, but had not yet recieved their own distinct HCPCS codes. Many drugs and NDC codes previously mapped to generic or miscellenous HCPCS codes, recieved their own unique HCPCS during the year of 2023.

This shift has created quite a few issues in the office-administered drug ‘Buy and Bill’ process:

  • NDC-HCPCS mapping: The sudden surge of 505(b)(2) HCPCS codes has made the NDC to HCPCS cross-walking process exceedingly complex. Many 505(b)(2) HCPCS are not listed on the CMS HCPCS-NDC crosswalk file, leaving providers stranded when it comes to NDC-HCPCS mapping.
  • Diminishing Importance of NOC: With the implementation of 505(b)(2) HCPCS codes, CMS has begun clearing out the various NOC (Not Otherwise Classified) files published on their site. A large number of NDCs previously linked to NOC codes no longer appear on the CMS database. This presents a confusing situation for providers using these NDCs.
  • Exteme ASP Fluctuation: The administration of new HCPCS codes for NDCs that were previously aligned to a single HCPCS can create heavy quarter-to-quarter ASP price fluctuations. Providers must be keenly aware of the HCPCS code they are utilizing to track how its ASP might be changing every quarter. Luckily for healthcare providers, BuyandBill.com provides highly accurate NDC-HCPCS alignments and several ASP monitoring tools. Just Login or Register to access our advanced features.

Below is a table containing all 505(b)(2) drugs and HCPCS codes as of April, 2024. Please note that our list is still being developed and could contain errors:

HCPCS CodeHCPCS DescriptorIngredient NameManufacturer
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 mgAcetaminophenB. Braun Medical Inc.
J0137Injection, acetaminophen (hikma) not therapeutically equivalent to j0131, 10 mgAcetaminophenHikma
J0171Injection, adrenalin, epinephrine, 0.1 mgEpinephrinePar Pharmaceutical, Inc
J0173Injection, epinephrine (belcher) not therapeutically equivalent to j0171, 0.1 mgEpinephrineBelcher
J0184Injection, amisulpride, 1 mgAmisulprideAcacia/Eagle
J0206Injection, allopurinol sodium, 1 mgAllopurinol SodiumGeneric Code (Multiple Manufacturers)
J0216Injection, alfentanil hydrochloride, 500 microgramsAlfentanil HydrochlorideAkorn
J0282Injection, amiodarone hydrochloride, 30 mgAmiodarone HydrochlorideFresenius Kabi
J0283Injection, amiodarone hydrochloride (nexterone), 30 mgAmiodarone HydrochlorideBaxter
J0391Injection, artesunate, 1 mgArtesunateAmivas
J0457Injection, aztreonam, 100 mgAztreonamGeneric Code (Multiple Manufacturers)
J0576Injection, buprenorphine extended-release (brixadi), 1 mgBuprenorphine Extended-ReleaseBraeburn
J0612Injection, calcium gluconate (fresenius kabi), per 10 mgCalcium GluconateFresenius Kabi
J0613Injection, calcium gluconate (wg critical care), per 10 mgCalcium GluconateWg Critical Care
J0665Injection, bupivicaine, not otherwise specified, 0.5 mgBupivicaineGeneric Code (Multiple Manufacturers)
J0688Injection, cefazolin sodium (hikma), not therapeutically equivalent to j0690, 500 mgCefazolin SodiumHikma
J0689Injection, cefazolin sodium (baxter), not therapeutically equivalent to j0690, 500 mgCefazolin SodiumBaxter
J0690Injection, cefazolin sodium, 500 mgCefazolinFresenius Kabi
J0692Injection, cefepime hydrochloride, 500 mgCefepime HydrochlorideGeneric Code (Multiple Manufacturers)
J0701Injection, cefepime hydrochloride (baxter), not therapeutically equivalent to maxipime, 500 mgCefepime HydrochlorideBaxter
J0703Injection, cefepime hydrochloride (b braun), not therapeutically equivalent to maxipime, 500 mgCefepime HydrochlorideB. Braun Medical Inc.
J0736Injection, clindamycin phosphate, 300 mgClindamycin PhosphateGeneric Code (Multiple Manufacturers)
J0737Injection, clindamycin phosphate (baxter), not therapeutically equivalent to j0736, 300 mgClindamycin PhosphateBaxter
J0873Injection, daptomycin (xellia) not therapeutically equivalent to j0878, 1 mgDaptomycinXellia
J0874Injection, daptomycin (baxter), not therapeutically equivalent to j0878, 1 mgDaptomycinBaxter
J0877Injection, daptomycin (hospira), not therapeutically equivalent to j0878, 1 mgDaptomycinHospira
J0878Injection, daptomycin, 1 mgDaptomycinGeneric Code (Multiple Manufacturers)
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 Healthcare Inc.
J0892Injection, argatroban (accord), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)ArgatrobanAccord Healthcare Inc.
J0893Injection, decitabine (sun pharma) not therapeutically equivalent to j0894, 1 mgDecitabineSun Pharmaceutical Global Fze.
J0894Injection, decitabine, 1 mgDecitabineGeneric Code (Multiple Manufacturers)
J0898Injection, argatroban (auromedics), not therapeutically equivalent to j0883, 1 mg (for non-esrd use)ArgatrobanAuromedics Pharma Llc
J0899Injection, argatroban (auromedics), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)ArgatrobanAuromedics Pharma Llc
J1105Dexmedetomidine, oral, 1 mcgDexmedetomidineBioxcel Therapeutics, Inc.
J1453Injection, fosaprepitant, 1 mgFosaprepitant For Injection 150 MgGeneric Code (Multiple Manufacturers)
J1456Injection, fosaprepitant (teva), not therapeutically equivalent to j1453, 1 mgFosaprepitantActavis Pharma, Inc.
J1570Injection, ganciclovir sodium, 500 mgGanciclovirGeneric Code (Multiple Manufacturers)
J1574Injection, ganciclovir sodium (exela) not therapeutically equivalent to j1570, 500 mgGanciclovir SodiumExela Pharma Sciences
J1576Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mgImmune GlobulinPfizer
J1596Injection, glycopyrrolate, 0.1 mgGlycopyrrolateGeneric Code (Multiple Manufacturers)
J1610Injection, glucagon hydrochloride, per 1 mgGvoke KitGeneric Code (Multiple Manufacturers)
J1611Injection, glucagon hydrochloride (fresenius kabi), not therapeutically equivalent to j1610, per 1 mgGlucagon HydrochlorideFresenius Kabi Usa, Llc
J1642Injection, heparin sodium, (heparin lock flush), per 10 unitsHeparinMedefil, Inc.
J1643Injection, heparin sodium (pfizer), not therapeutically equivalent to j1644, per 1000 unitsHeparin SodiumPfizer Inc.
J1644Injection, heparin sodium, per 1000 unitsHeparin SodiumFresenius Kabi
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
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 unitsInsulinEli Lilly And Company
J1814Insulin (lyumjev), per 5 unitsInsulinEli Lilly And Company
J1836Injection, metronidazole, 10 mgMetronidazoleGeneric Code (Multiple Manufacturers)
J1920Injection, labetalol hydrochloride, 5 mgLabetalol HydrochlorideGeneric Code (Multiple Manufacturers)
J1921Injection, labetalol hydrochloride (hikma) not therapeutically equivalent to j1920, 5 mgLabetalol HydrochlorideHikma
J1939Injection, bumetanide, 0.5 mgBumetanideGeneric Code (Multiple Manufacturers)
J1940Injection, furosemide, up to 20 mgFurosemideGeneric Code (Multiple Manufacturers)
J1941Injection, furosemide (furoscix), 20 mgFurosemideSc Pharmaceuticals
J1950Injection, leuprolide acetate (for depot suspension), per 3.75 mgLeuprolide AcetateAbbvie Us, Llc
J1951Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mgLeuprolide AcetateTolmar
J1952Leuprolide injectable, camcevi, 1 mgLeuprolide AcetateAccord Biopharma Inc.
J1954Injection, leuprolide acetate for depot suspension (cipla), 7.5 mgLeuprolide AcetateCipla
J2020Injection, linezolid, 200 mgLinezolidGeneric Code (Multiple Manufacturers)
J2021Injection, linezolid (hospira) not therapeutically equivalent to j2020, 200 mgLinezolidPfizer Inc.
J2184Injection, meropenem (b. braun) not therapeutically equivalent to j2185, 100 mgMeropenemB. Braun Medical Inc.
J2185Injection, meropenem, 100 mgMeropenemGeneric Code (Multiple Manufacturers)
J2186Injection, meropenem and vaborbactam, 10mg/10mg (20mg)VabomereMelinta Therapeutics, Inc.
J2247Injection, micafungin sodium (par pharm) not thereapeutically equivalent to j2248, 1 mgMicafungin SodiumPar Pharmaceutical, Inc
J2248Injection, micafungin sodium, 1 mgMicafungin SodiumGeneric Code (Multiple Manufacturers)
J2250Injection, midazolam hydrochloride, per 1 mgMidazolam HclGeneric Code (Multiple Manufacturers)
J2251Injection, midazolam hydrochloride (wg critical care) not therapeutically equivalent to j2250, per 1 mgMidazolam HydrochlorideWg Critical Care
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 SulfateHikma Pharmaceuticals Usa Inc.
J2280Injection, moxifloxacin, 100 mgMoxifloxacin HclGeneric Code (Multiple Manufacturers)
J2281Injection, moxifloxacin (fresenius kabi) not therapeutically equivalent to j2280, 100 mgMoxifloxacinFresenius Kabi
J2305Injection, nitroglycerin, 5 mgNitroglycerinGeneric Code (Multiple Manufacturers)
J2310Injection, naloxone hydrochloride, per 1 mgNaloxone HydrochlorideGeneric Code (Multiple Manufacturers)
J2311Injection, naloxone hydrochloride (zimhi), 1 mgNaloxone HydrochlorideUs Worldmeds, Llc
J2359Injection, olanzapine, 0.5 mgOlanzapineGeneric Code (Multiple Manufacturers)
J2371Injection, phenylephrine hydrochloride, 20 microgramsPhenylephrine HydrochlorideGeneric Code (Multiple Manufacturers)
J2372Injection, phenylephrine hydrochloride (biorphen), 20 microgramsPhenylephrine HydrochlorideDr.Reddy'S Laboratories, Inc.
J2401Injection, chloroprocaine hydrochloride, per 1 mgChloroprocaine HydrochlorideGeneric Code (Multiple Manufacturers)
J2402Injection, chloroprocaine hydrochloride (clorotekal), per 1 mgChloroprocaine HydrochlorideB. Braun
J2403Chloroprocaine hcl ophthalmic, 3% gel, 1 mgChloroprocaine HclHarrow Eye
J2404Injection, nicardipine, 0.1 mgNicardipineGeneric Code (Multiple Manufacturers)
J2426Injection, paliperidone palmitate extended release (invega sustenna), 1 mgPaliperidone Palmitate Extended ReleaseJanssen
J2427Injection, paliperidone palmitate extended release (invega hafyera, or invega trinza), 1 mgPaliperidone Palmitate Extended ReleaseJanssen
J2560Injection, phenobarbital sodium, up to 120 mgPhenobarbital SodiumGeneric Code (Multiple Manufacturers)
J2561Injection, phenobarbital sodium (sezaby), 1 mgPhenobarbital SodiumSun Pharmaceutical Industries
J2598Injection, vasopressin, 1 unitVasopressinGeneric Code (Multiple Manufacturers)
J2599Injection, vasopressin (american regent) not therapeutically equivalent to j2598, 1 unitVasopressinAmerican Regent
J2679Injection, fluphenazine hcl, 1.25 mgFluphenazineFresenius Kabi
J2680Injection, fluphenazine decanoate, up to 25 mgFluphenazineGeneric Code (Multiple Manufacturers)
J2794Injection, risperidone (risperdal consta), 0.5 mgRisperidoneJanssen
J2798Injection, risperidone, (perseris), 0.5 mgRisperidoneIndivior
J2799Injection, risperidone (uzedy), 1 mgRisperidoneTeva
J2805Injection, sincalide, 5 microgramsSincalideGeneric Code (Multiple Manufacturers)
J2806Injection, sincalide (maia) not therapeutically equivalent to j2805, 5 microgramsSincalideMaia
J3243Injection, tigecycline, 1 mgTigecyclineGeneric Code (Multiple Manufacturers)
J3244Injection, tigecycline (accord) not therapeutically equivalent to j3243, 1 mgTigecyclineAccord Healthca
J3370Injection, vancomycin hcl, 500 mgVancomycin HclGeneric Code (Multiple Manufacturers)
J3371Injection, vancomycin hcl (mylan) not therapeutically equivalent to j3370, 500 mgVancomycin HclMylan Institutional Llc
J3372Injection, vancomycin hcl (xellia) not therapeutically equivalent to j3370, 500 mgVancomycin HclXellia Pharmaceuticals Usa, Llc
J3425Injection, hydroxocobalamin, 10 mcgHydroxocobalaminActavis
J7213Injection, coagulation factor ix (recombinant), ixinity, 1 i.u.Coagulation Factor Ix Medexus Pharma
J7519Injection, mycophenolate mofetil, 10 mgMycophenolate MofetilGeneric Code (Multiple Manufacturers)
J9033Injection, bendamustine hcl (treanda), 1 mgBendamustine HydrochlorideGeneric Code (Multiple Manufacturers)
J9034Injection, bendamustine hcl (bendeka), 1 mgBendamustine HydrochlorideCephalon Inc.
J9036Injection, bendamustine hydrochloride, (belrapzo/bendamustine), 1 mgBendamustine HydrochlorideEagle Pharmaceuticals, Inc.
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, Inc.
J9051Injection, bortezomib (maia), not therapeutically equivalent to j9041, 0.1 mgBortezomibMaia
J9050Injection, carmustine, 100 mgCarmustineGeneric Code (Multiple Manufacturers)
J9052Injection, carmustine (accord), not therapeutically equivalent to j9050, 100 mgCarmustineAccord
J9056Injection, bendamustine hydrochloride (vivimusta), 1 mgBendamustine HydrochlorideSlayback Pharma
J9058Injection, bendamustine hydrochloride (apotex), 1 mgBendamustine HydrochlorideApotex Corp
J9059Injection, bendamustine hydrochloride (baxter), 1 mgBendamustine HydrochlorideBaxter Healthcare Corp.
J9043Injection, cabazitaxel, 1 mgCabazitaxelSanofi-Aventis
J9064Injection, cabazitaxel (sandoz), not therapeutically equivalent to j9043, 1 mgCabazitaxelSandoz
J9070Cyclophosphamide, 100 mgCyclophosphamideGeneric Code (Multiple Manufacturers)
J9071Injection, cyclophosphamide, (auromedics), 5 mgCyclophosphamideAuromedics
J9072Injection, cyclophosphamide, (dr. reddy's), 5 mgCyclophosphamideDr.Reddy'S Laboratories, Inc.
J9171Injection, docetaxel, 1 mgDocetaxelGeneric Code (Multiple Manufacturers)
J9172Injection, docetaxel (ingenus) not therapeutically equivalent to j9171, 1 mgDocetaxelIngenus
J9196Injection, gemcitabine hydrochloride (accord), not therapeutically equivalent to j9201, 200 mgGemcitabine HydrochlorideAccord Healthcare Inc.
J9198Injection, gemcitabine hydrochloride, (infugem), 100 mgInfugemSun Pharmaceutical Industries, Ltd.
J9201Injection, gemcitabine hydrochloride, not otherwise specified, 200 mgGemcitabineGeneric Code (Multiple Manufacturers)
J9217Leuprolide acetate (for depot suspension), 7.5 mgLeuprolide AcetateTolmar
J9258Injection, paclitaxel protein-bound particles (teva) not therapeutically equivalent to j9264, 1 mgPaclitaxelTeva
J9259Injection, paclitaxel protein-bound particles (american regent) not therapeutically equivalent to j9264, 1 mgPaclitaxelAmerican Regent
J9264Injection, paclitaxel protein-bound particles, 1 mgPaclitaxelGeneric Code (Multiple Manufacturers)
J9267Injection, paclitaxel, 1 mgPaclitaxelGeneric Code (Multiple Manufacturers)
J9294Injection, pemetrexed (hospira) not therapeutically equivalent to j9305, 10 mgPemetrexedHospira, Inc.
J9296Injection, pemetrexed (accord) not therapeutically equivalent to j9305, 10 mgPemetrexedAccord Healthcare Inc.
J9297Injection, pemetrexed (sandoz), not therapeutically equivalent to j9305, 10 mgPemetrexedSandoz
J9304Injection, pemetrexed (pemfexy), 10 mgPemetrexedEagle Pharmaceuticals, Inc.
J9305Injection, pemetrexed, not otherwise specified, 10 mgPemetrexedGeneric Code (Multiple Manufacturers)
J9314Injection, pemetrexed (teva) not therapeutically equivalent to j9305, 10 mgPemetrexedTeva Pharmaceuticals Usa, Inc.
J9322Injection, pemetrexed (bluepoint) not therapeutically equivalent to j9305, 10 mgPemetrexedBluepoint
J9323Injection, pemetrexed ditromethamine, 10 mgPemetrexedHospira, Inc.
J9324Injection, pemetrexed (pemrydi rtu), 10 mgPemetrexedHospira, Inc.
J9393Injection, fulvestrant (teva) not therapeutically equivalent to j9395, 25 mgFulvestrantTeva
J9394Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mgFulvestrantFresenius Kabi
J9395Injection, fulvestrant, 25 mgFulvestrantGeneric Code (Multiple Manufacturers)
J9073Injection, cyclophosphamide (ingenus), 5 mgCyclophosphamideIngenus
J9075Injection, cyclophosphamide, not otherwise specified, 5 mgCyclophosphamideNorthstar Rx Llc
J0577Injection, buprenorphine extended-release (brixadi), less than or equal to 7 days of therapyBuprenorphine Extended-ReleaseBraeburn Pharmaceuticals
J0578Injection, buprenorphine extended-release (brixadi), greater than 7 days and up to 28 days of therapyBuprenorphine Extended-ReleaseBraeburn Pharmaceuticals
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 Pharmaceuticals Usa Inc.
J1010Injection, methylprednisolone acetate, 1 mgmethylprednisolone acetateAmneal Biosciences
J2919Injection, methylprednisolone sodium succinate, 5 mgmethylprednisolone sodium succinateFresenius Kabi