infliximab-abda 100 MG Injection
- RxCUI
- 1927285
- RxNorm name
- infliximab-abda 100 MG Injection
- Display name
- infliximab-abda 100 MG Injection
- Full name
- infliximab-abda 100 MG Injection
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:54
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761054 | Renflexis | infliximab-abda | 351(k) Biosimilar | Rx | 2026-08-01 |
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 |
|---|---|---|---|---|---|---|
| Renflexis | INFLIXIMAB | Organon LLC | dbf738c4-3fac-4422-a9d8-51d9c83a8789 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 1927285 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 3827e1be-f328-45f7-b113-311b57039f8c | inFLIXimab-abda 100 MG Injection [PSN] · infliximab-abda 100 MG Injection [SCD] | 2 | 14 | These highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) 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 differe | 20230126 |
| dbf738c4-3fac-4422-a9d8-51d9c83a8789 | inFLIXimab-abda 100 MG Injection [PSN] · infliximab-abda 100 MG Injection [SCD] | 2 | 6 | These highlights do not include all the information needed to use RENFLEXIS ® safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) 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 | 20251105 |