0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
- RxCUI
- 2677787
- RxNorm name
- 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
- Display name
- 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
- Full name
- 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:48
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761299 | Simlandi | adalimumab-ryvk | 351(k) Interchangeable | Rx | 2026-06-01 |
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 |
|---|---|---|---|---|---|---|
| Simlandi | ADALIMUMAB-RYVK | Teva Pharmaceuticals USA, Inc. | 12f609c9-2088-bb05-e063-6394a90a9ecc | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 2677787 |
| Simlandi | ADALIMUMAB-RYVK | A-S Medication Solutions | ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 2677787 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 12f609c9-2088-bb05-e063-6394a90a9ecc | Simlandi 40 MG in 0.4 ML Auto-Injector | PSN | 24 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251222 |
| 12f609c9-2088-bb05-e063-6394a90a9ecc | Simlandi 40 MG per 0.4 ML Auto-Injector | SY | 24 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251222 |
| 12f609c9-2088-bb05-e063-6394a90a9ecc | 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi] | SBD | 24 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251222 |
| ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f | Simlandi 40 MG in 0.4 ML Auto-Injector | PSN | 1 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251016 |
| ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f | 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi] | SBD | 1 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251016 |
| ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f | Simlandi 40 MG per 0.4 ML Auto-Injector | SY | 1 | These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 differences | 20251016 |