0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
- RxCUI
- 2640895
- RxNorm name
- 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
- Display name
- 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
- Full name
- 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:47
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761058 | Cyltezo | adalimumab-adbm | 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 |
|---|---|---|---|---|---|---|
| Cyltezo | ADALIMUMAB-ADBM | Boehringer Ingelheim Pharmaceuticals, Inc. | 115ea79b-7209-7f19-b35d-36ec0828fbf5 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 2640895 |
| Adalimumab-adbm | ADALIMUMAB-ADBM | Boehringer Ingelheim Pharmaceuticals, Inc. | 62f39a7c-00df-4519-a8d4-39bbd0a649ed | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | 2640895 |
| Adalimumab-adbm | ADALIMUMAB-ADBM | QUALLENT PHARMACEUTICALS HEALTH LLC | f9986706-9c75-4335-a54f-09d7716dbcef | 2024-11-12 | Boxed warning, Warnings, Adverse reactions | 2640895 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 115ea79b-7209-7f19-b35d-36ec0828fbf5 | 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector | SCD | 17 | These highlights do not include all the information needed to use CYLTEZO safely and effectively. See full prescribing information for CYLTEZO. CYLTEZO ® (adalimumab-adbm) injection, for subcutaneous use Initial U.S. Approval: 2017 CYLTEZO (adalimumab-adbm) 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 betw | 20260303 |
| 115ea79b-7209-7f19-b35d-36ec0828fbf5 | adalimumab-adbm 40 MG in 0.8 ML Auto-Injector | PSN | 17 | These highlights do not include all the information needed to use CYLTEZO safely and effectively. See full prescribing information for CYLTEZO. CYLTEZO ® (adalimumab-adbm) injection, for subcutaneous use Initial U.S. Approval: 2017 CYLTEZO (adalimumab-adbm) 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 betw | 20260303 |
| 115ea79b-7209-7f19-b35d-36ec0828fbf5 | adalimumab-adbm 40 MG per 0.8 ML Auto-Injector | SY | 17 | These highlights do not include all the information needed to use CYLTEZO safely and effectively. See full prescribing information for CYLTEZO. CYLTEZO ® (adalimumab-adbm) injection, for subcutaneous use Initial U.S. Approval: 2017 CYLTEZO (adalimumab-adbm) 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 betw | 20260303 |
| 62f39a7c-00df-4519-a8d4-39bbd0a649ed | adalimumab-adbm 40 MG in 0.8 ML Auto-Injector | PSN | 5 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20251112 |
| 62f39a7c-00df-4519-a8d4-39bbd0a649ed | 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector | SCD | 5 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20251112 |
| 62f39a7c-00df-4519-a8d4-39bbd0a649ed | adalimumab-adbm 40 MG per 0.8 ML Auto-Injector | SY | 5 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20251112 |
| f9986706-9c75-4335-a54f-09d7716dbcef | 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector | SCD | 3 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20241112 |
| f9986706-9c75-4335-a54f-09d7716dbcef | adalimumab-adbm 40 MG in 0.8 ML Auto-Injector | PSN | 3 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20241112 |
| f9986706-9c75-4335-a54f-09d7716dbcef | adalimumab-adbm 40 MG per 0.8 ML Auto-Injector | SY | 3 | These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th | 20241112 |