trastuzumab-pkrb 21 MG/ML Injectable Solution

RxCUI: 2107053
RxNorm name: trastuzumab-pkrb 21 MG/ML Injectable Solution
Display name: trastuzumab-pkrb 21 MG/ML Injectable Solution
Full name: trastuzumab-pkrb 21 MG/ML Injectable Solution
Term type: SCD
Status: DailyMed mapping
Updated: 2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761091	Herzuma	trastuzumab-pkrb	351(k) Biosimilar	Rx	2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier rxcui: 2107053

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
ae71c003-883a-4cd8-ad50-e8cc9a54e971	trastuzumab-pkrb 21 MG/ML Injectable Solution	SCD	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	trastuzumab-pkrb 420 MG in 20 ML Injectable Solution	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	trastuzumab-pkrb 420 MG per 20 ML Injectable Solution	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