0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]
- RxCUI
- 2724431
- RxNorm name
- 0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]
- Display name
- 0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]
- Full name
- 0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:07
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | Rx | 2026-07-01 |
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Otulfi | USTEKINUMAB-AAUZ | Fresenius Kabi USA, LLC | 853130e5-7406-4fd6-8138-ff2179195927 | 2026-02-16 | Warnings, Adverse reactions | 2724431 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 853130e5-7406-4fd6-8138-ff2179195927 | Otulfi 45 MG in 0.5 ML Injection [PSN] · 0.5 ML ustekinumab-aauz 90 MG/ML Injection [Otulfi] [SBD] · 0.5 ML Otulfi 90 MG/ML Injection [SY] · Otulfi 45 MG per 0.5 ML Injection [SY] | 4 | 4 | These highlights do not include all the information needed to use OTULFI safely and effectively. See full prescribing information for OTULFI. OTULFI (ustekinumab-aauz) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 OTULFI (ustekinumab-aauz) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe | 20260216 |