UDENYCA 6 MG in 0.6 ML Auto-Injector

RxCUI: 2632547
RxNorm name: UDENYCA 6 MG in 0.6 ML Auto-Injector
Display name: UDENYCA 6 MG in 0.6 ML Auto-Injector
Full name: UDENYCA 6 MG in 0.6 ML Auto-Injector
Term type: PSN
Status: DailyMed mapping
Updated: 2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761039	Udenyca	pegfilgrastim-cbqv	351(k) Biosimilar	Rx	2026-08-01

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#

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UDENYCA	PEGFILGRASTIM-CBQV	Accord BioPharma, Inc.	77a8576f-b91e-42ce-b613-2fa3c3d4a571	2026-04-23	Warnings, Adverse reactions	Exact identifier rxcui: 2632547
UDENYCA	PEGFILGRASTIM-CBQV	Coherus Oncology, Inc.	a8c290ee-b699-4395-a596-1453d4a4b4eb	2025-08-14	Warnings, Adverse reactions	Exact identifier rxcui: 2632547

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
a8c290ee-b699-4395-a596-1453d4a4b4eb	UDENYCA 6 MG in 0.6 ML Auto-Injector [PSN] · 0.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector [Udenyca] [SBD] · 0.6 ML Udenyca 10 MG/ML Auto-Injector [SY] · Udenyca 6 MG per 0.6 ML Auto-Injector [SY]	4	13	These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) 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 difference	20250814
77a8576f-b91e-42ce-b613-2fa3c3d4a571	UDENYCA 6 MG in 0.6 ML Auto-Injector [PSN] · 0.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector [Udenyca] [SBD] · 0.6 ML Udenyca 10 MG/ML Auto-Injector [SY] · Udenyca 6 MG per 0.6 ML Auto-Injector [SY]	4	4	These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) 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 difference	20260423