Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)
- RxCUI
- 2640903
- RxNorm name
- Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)
- Display name
- Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)
- Full name
- Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)
- Term type
- SY
- 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 | 2640903 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 115ea79b-7209-7f19-b35d-36ec0828fbf5 | Cyltezo Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count) | 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 |
| 115ea79b-7209-7f19-b35d-36ec0828fbf5 | CYLTEZO Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count) | 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 | {6 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [Cyltezo]) } Pack [Cyltezo Pen 40 MG/0.8 ML Starter Package for Crohn's Disease or Ulcerative Colitis] | BPCK | 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 |