Otulfi Q Code: Q9999
Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg
Q4 2026 Medicare Payment Limit for Q9999, effective October 1, 2026: $13.246 per HCPCS billing unit, up 0.7% from $13.154. From CMS's final file.
Drug & Product Overview
About Otulfi
Otulfi is a medication aligned to the HCPCS Q Code: Q9999 for billing, pricing, and reimbursement purposes in the United States. It is an Immunology drug administered via the intravenous or subcutaneous routes and manufactured by Fresenius Kabi.
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NDC Code Information
Based on publicly available CMS files. Showing 5 of 6 NDCs — log in for the full crosswalk.
| NDC Code | Drug | Manufacturer | Billing Units / Pkg | Package Size |
|---|---|---|---|---|
| 65219-0822-05 | Otulfi | Fresenius Kabi USA, LLC | 45 | 45 MG / 0.5 ML |
| 65219-0824-01 | Otulfi | Fresenius Kabi USA, LLC | 45 | 45 MG / 0.5 ML |
| 65219-0826-26 | Otulfi | Fresenius Kabi USA, LLC | 90 | 90 MG / 1 ML |
| 65219-0828-05 | Otulfi | Fresenius Kabi USA, LLC | 130 | 130 MG / 26 ML |
| 65219-0862-01 | Ustekinumab-Aauz | Fresenius Kabi USA, LLC | 45 | 45 MG / 0.5 ML |
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Otulfi Pricing & Reimbursement
National median reimbursement across major commercial payers.
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Login to use the calculator →Ustekinumab Biosimilar Information:
Otulfi Approval Date: September 27, 2024
| 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 |
Otulfi 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) |
| 96372 Login for More | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular Login for More |
This product is new and does not yet appear on the CMS list of HCPCS pertaining to single-dose containers. Wastage billing guide →
Otulfi Medically Unlikely Edits (MUE)
The most billing units of Q9999 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 →
Otulfi 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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