FDA.reportPublic FDA data

UDENYCA

Product NDC
70114-130
11-digit product format
701140130
Labeler code
70114
Product ID
70114-130_7a30003f-a148-4c35-bf21-b4822e970eb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim-cbqv
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Coherus Oncology, Inc.
Application
BLA761039
Marketing category
BLA
Marketing start
2023-12-22
Substance
PEGFILGRASTIM
Active strength
6 mg/.6mL
Pharmacologic classes
Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UDENYCA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGFILGRASTIM6 mg/.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3A58010674Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2102703Internal RxNorm lookup
2102705Internal RxNorm lookup
2632544Internal RxNorm lookup
2632547Internal RxNorm lookup
2673598Internal RxNorm lookup
2673602Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8c290ee-b699-4395-a596-1453d4a4b4ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
7979a9c8-e75a-40a9-87cc-a5f08355aaefProduct name120230626
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c3bb58c9-5c71-4b39-a70d-70acbffd3efeProduct name120230127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37Product name120150402
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70114-130-012025-08-14C16284748780-13b156c62-28d9-fb37-e063-e6dba90a4e07These 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
70114-130-012025-07-29C16284748780-13b156c62-28d9-fb37-e063-e6dba90a4e07These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70114-130-01UDENYCA1 in 1 CARTONINJECTION, SOLUTION113
70114-130-01UDENYCA0.6 mL in 1 SYRINGEINJECTION, SOLUTION0.613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70114-130-01ML - Milliliter70114-130f7f2231d-b652-4e76-b58e-ecd514bba1d212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70114-130UDENYCA (PEGFILGRASTIM-CBQV) INJECTION, SOLUTION [COHERUS BIOSCIENCES INC]12Current NDC, 2 package rows20240822_a8c290ee-b699-4395-a596-1453d4a4b4eb.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UDENYCAPEGFILGRASTIM-CBQVAccord BioPharma, Inc.77a8576f-b91e-42ce-b613-2fa3c3d4a5712026-04-23Warnings, Adverse reactionsExact identifier
application number: BLA761039
UDENYCAPEGFILGRASTIM-CBQVCoherus Oncology, Inc.a8c290ee-b699-4395-a596-1453d4a4b4eb2025-08-14Warnings, Adverse reactionsExact identifier
application number: BLA761039
ndc (product): 70114-130

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761039Udenycapegfilgrastim-cbqv351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632544pegfilgrastim-cbqv 6 MG in 0.6 ML Auto-InjectorPSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
2673598pegfilgrastim-cbqv 6 MG in 0.6 ML On-body InjectionPSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
2102703pegfilgrastim-cbqv 6 MG in 0.6 ML Prefilled SyringePSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
2632547UDENYCA 6 MG in 0.6 ML Auto-InjectorPSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
2673602UDENYCA 6 MG in 0.6 ML Onbody InjectionPSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
2102705UDENYCA 6 MG in 0.6 ML Prefilled SyringePSNa8c290ee-b699-4395-a596-1453d4a4b4eb13
26325470.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector [Udenyca]SBDa8c290ee-b699-4395-a596-1453d4a4b4eb13
26736020.6 ML pegfilgrastim-cbqv 10 MG/ML Injection [Udenyca]SBDa8c290ee-b699-4395-a596-1453d4a4b4eb13
21027050.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe [Udenyca]SBDa8c290ee-b699-4395-a596-1453d4a4b4eb13
26325440.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-InjectorSCDa8c290ee-b699-4395-a596-1453d4a4b4eb13
26735980.6 ML pegfilgrastim-cbqv 10 MG/ML InjectionSCDa8c290ee-b699-4395-a596-1453d4a4b4eb13
21027030.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled SyringeSCDa8c290ee-b699-4395-a596-1453d4a4b4eb13
26325470.6 ML Udenyca 10 MG/ML Auto-InjectorSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
26736020.6 ML Udenyca 10 MG/ML InjectionSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
21027050.6 ML Udenyca 10 MG/ML Prefilled SyringeSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
2632544pegfilgrastim-cbqv 6 MG per 0.6 ML Auto-InjectorSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
2673598pegfilgrastim-cbqv 6 MG per 0.6 ML On-body InjectionSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
2632547Udenyca 6 MG per 0.6 ML Auto-InjectorSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
2673602Udenyca 6 MG per 0.6 ML Onbody InjectionSYa8c290ee-b699-4395-a596-1453d4a4b4eb13
2102705Udenyca 6 MG per 0.6 ML Prefilled SyringeSYa8c290ee-b699-4395-a596-1453d4a4b4eb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70114-130-01701140130011 SYRINGE in 1 CARTON (70114-130-01) / .6 mL in 1 SYRINGE1 syringe2023-12-22NoNoCurrent