glofitamab-gxbm 2.5 MG per 2.5 ML Injection
- RxCUI
- 2639794
- RxNorm name
- glofitamab-gxbm 2.5 MG per 2.5 ML Injection
- Display name
- glofitamab-gxbm 2.5 MG per 2.5 ML Injection
- Full name
- glofitamab-gxbm 2.5 MG per 2.5 ML Injection
- Term type
- SY
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:53
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761309 | Columvi | glofitamab-gxbm | 351(a) | 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 |
|---|---|---|---|---|---|---|
| Columvi | GLOFITAMAB | Genentech, Inc. | 3516e753-f064-4d30-9bd5-e3f2e143f75d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 2639794 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 3516e753-f064-4d30-9bd5-e3f2e143f75d | glofitamab-gxbm 2.5 MG in 2.5 ML Injection [PSN] · 2.5 ML glofitamab-gxbm 1 MG/ML Injection [SCD] · glofitamab-gxbm 2.5 MG per 2.5 ML Injection [SY] | 3 | 7 | These highlights do not include all the information needed to use COLUMVI ® safely and effectively. See full prescribing information for COLUMVI. COLUMVI (glofitamab-gxbm) injection, for intravenous use Initial U.S. Approval: 2023 | 20251103 |