trastuzumab-pkrb 150 MG Injection [Herzuma]
- RxCUI
- 2169362
- RxNorm name
- trastuzumab-pkrb 150 MG Injection [Herzuma]
- Display name
- trastuzumab-pkrb 150 MG Injection [Herzuma]
- Full name
- trastuzumab-pkrb 150 MG Injection [Herzuma]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:15
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761091 | Herzuma | trastuzumab-pkrb | 351(k) Biosimilar | 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 |
|---|---|---|---|---|---|---|
| HERZUMA | TRASTUZUMAB | Cephalon, Inc. | ae71c003-883a-4cd8-ad50-e8cc9a54e971 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | 2169362 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| ae71c003-883a-4cd8-ad50-e8cc9a54e971 | trastuzumab-pkrb 150 MG Injection [Herzuma] | SBD | 14 | These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA ® (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) 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 | 20251222 |
| ae71c003-883a-4cd8-ad50-e8cc9a54e971 | Herzuma 150 MG Injection | PSN | 14 | These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA ® (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) 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 | 20251222 |
| ae71c003-883a-4cd8-ad50-e8cc9a54e971 | Herzuma 150 MG Injection | SY | 14 | These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA ® (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) 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 | 20251222 |