FDA.reportPublic FDA data

UDENYCA

Product NDC
70114-101
11-digit product format
701140101
Labeler code
70114
Product ID
70114-101_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
2018-11-02
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 Identifiers#

Field, Values table
FieldValues
Unii3A58010674
Rxcui2102703, 2102705, 2632544, 2632547, 2673598, 2673602

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
70114-101-012025-08-14C16284748780-13b156c62-28d9-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
70114-101-012025-07-29C16284748780-13b156c62-28d9-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
70114-101-01UDENYCA0.6 mL in 1 SYRINGEINJECTION, SOLUTION0.613
70114-101-01UDENYCA1 in 1 CARTONINJECTION, SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70114-101-01ML - Milliliter70114-101fbbe193c-cea6-4772-95cc-cc0e8bba973012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70114-101UDENYCA (PEGFILGRASTIM-CBQV) INJECTION, SOLUTION [COHERUS BIOSCIENCES INC]12Current NDC, Legacy NDC, 2 package rows20240822_a8c290ee-b699-4395-a596-1453d4a4b4eb.zip

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 startMarketing endSampleExclude flagStatus
70114-101-01701140101011 SYRINGE in 1 CARTON (70114-101-01) / .6 mL in 1 SYRINGE1 syringe2018-11-020000-00-00NoNoCurrent