STELARA J Code: J3358
Ustekinumab, for intravenous injection, 1 mg
Q4 2026 Medicare Payment Limit for J3358, effective October 1, 2026: $10.249 per HCPCS billing unit, down 9.7% from $11.356. From CMS's final file.
Drug & Product Overview
About STELARA
Stelara is a medication aligned to the HCPCS J Code: J3358 for billing, pricing, and reimbursement purposes in the United States. It is an Immunology drug administered via the intravenous route and manufactured by Janssen.
According to CMS Drug Use Information: Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis. This monograph is about the following ustekinumab products: ustekinumab, ustekinumab-aauz, ustekinumab-aekn, ustekinumab-auub, ustekinumab-hmny, ustekinumab-kfce, ustekinumab-srlf, ustekinumab-stba, ustekinumab-ttwe.
Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.
NDC Code Information
Based on publicly available CMS files. The list of NDCs below is not exhaustive.
| NDC Code | Drug | Manufacturer | Billing Units / Pkg | Package Size |
|---|---|---|---|---|
| 57894-0054-27 | Stelara | Janssen Biotech, Inc. | 130 | 130 MG / 26 ML |
| 57894-0444-01 | ustekinumab | Janssen Biotech, Inc. | 130 | 130 MG / 26 ML |
STELARA Pricing & Reimbursement
National median reimbursement across major commercial payers.
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Login to use the calculator →Ustekinumab Biosimilar Information:
STELARA Approval Date: September 23, 2016
| Product Name | HCPCS Code | Active Ingredient | BLA Type |
|---|---|---|---|
| Stelara | J3358 | Ustekinumab | 351(a) Originator Product |
| Wezlana | Q5137 | Ustekinumab | 351(k) Interchangeable |
| Wezlana | Q5138 | Ustekinumab | 351(k) Interchangeable |
| Selarsdi | Q9998 | Ustekinumab | 351(k) Interchangeable |
| Pyzchiva | Q9996 | Ustekinumab | 351(k) Interchangeable |
| Pyzchiva | Q9997 | Ustekinumab | 351(k) Interchangeable |
| Otulfi | Q9999 | Ustekinumab | 351(k) Interchangeable |
| Imuldosa | Q5098 | Ustekinumab | 351(k) Interchangeable |
| Yesintek | Q5100 | Ustekinumab | 351(k) Interchangeable |
| Steqeyma | Q5099 | Ustekinumab | 351(k) Interchangeable |
| Starjemza | Q5164 | Ustekinumab | 351(k) Interchangeable |
STELARA CPT Administration Codes
The below list of CPT codes is intended for informational purposes only and may not be exhaustive. CPT® codes and descriptions are copyright American Medical Association (AMA). All rights reserved.
| CPT Code | Description |
|---|---|
| 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour |
| 96366 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) |
CMS has identified Stelara (J3358) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →
STELARA Medically Unlikely Edits (MUE)
The most billing units of J3358 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.
MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →
STELARA Clinical Information
Indications and drug classification.
This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.
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Frequently Asked Questions
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