ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe
- RxCUI
- 2705393
- RxNorm name
- ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe
- Display name
- ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe
- Full name
- ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:07
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761343 | Selarsdi | ustekinumab-aekn | 351(k) Interchangeable | Rx | 2026-06-01 |
UNII Substances#
No records found.
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ustekinumab-aekn | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | 2026-07-30 | Warnings, Adverse reactions | 2705393 |
| Ustekinumab-aekn | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | 2026-07-24 | Warnings, Adverse reactions | 2705393 |
| Selarsdi | USTEKINUMAB-AEKN | Teva Pharmaceuticals USA, Inc. | 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | 2026-06-24 | Warnings, Adverse reactions | 2705393 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe | PSN | 13 | These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning | 20251203 |
| 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | ustekinumab-aekn 90 MG/ML per 0.5 ML Prefilled Syringe | SY | 13 | These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning | 20251203 |
| 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | 0.5 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe | SCD | 13 | These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning | 20251203 |
| 87f75b59-e48b-47c7-a4c0-5fe5965660e7 | ustekinumab-aekn 45 MG per 0.5 ML Prefilled Syringe | SY | 13 | These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning | 20251203 |
| 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe | PSN | 9 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20251203 |
| 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | ustekinumab-aekn 45 MG per 0.5 ML Prefilled Syringe | SY | 9 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20251203 |
| 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | 0.5 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe | SCD | 9 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20251203 |
| 183a1dff-ef33-4ddb-ba38-f7861b0f77ad | ustekinumab-aekn 90 MG/ML per 0.5 ML Prefilled Syringe | SY | 9 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20251203 |
| 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | 0.5 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe | SCD | 6 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20260225 |
| 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | ustekinumab-aekn 45 MG in 0.5 ML Prefilled Syringe | PSN | 6 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20260225 |
| 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | ustekinumab-aekn 45 MG per 0.5 ML Prefilled Syringe | SY | 6 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20260225 |
| 052a3fb2-21c3-4c4e-a01e-afdd1accd1cd | ustekinumab-aekn 90 MG/ML per 0.5 ML Prefilled Syringe | SY | 6 | These highlights do not include all the information needed to use USTEKINUMAB-AEKN safely and effectively. See full prescribing information for USTEKINUMAB-AEKN . USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 Ustekinumab-aekn 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 di | 20260225 |