inFLIXimab-dyyb 100 MG Injection
- RxCUI
- 1790541
- RxNorm name
- inFLIXimab-dyyb 100 MG Injection
- Display name
- inFLIXimab-dyyb 100 MG Injection
- Full name
- inFLIXimab-dyyb 100 MG Injection
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:54
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125544 | Inflectra | infliximab-dyyb | 351(k) Biosimilar | Rx | 2026-07-01 |
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 |
|---|---|---|---|---|---|---|
| INFLECTRA | INFLIXIMAB-DYYB | Pfizer Laboratories Div Pfizer Inc | 37eaca10-d812-48bc-8b8e-b836bfa9968f | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 1790541 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 37eaca10-d812-48bc-8b8e-b836bfa9968f | inFLIXimab-dyyb 100 MG Injection [PSN] · infliximab-dyyb 100 MG Injection [SCD] | 2 | 23 | These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) 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 | 20250910 |