FDA.reportPublic FDA data

BAVENCIO

Product NDC
44087-3535
11-digit product format
440873535
Labeler code
44087
Product ID
44087-3535_8e1f3b1c-5aab-408c-930e-619daa6afa8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avelumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
EMD Serono, Inc.
Application
BLA761049
Marketing category
BLA
Marketing start
2017-03-23
Substance
AVELUMAB
Active strength
20 mg/mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVELUMAB20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKXG2PJ551I
Rxcui1875542, 1875547

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d765d09a-89e5-47af-8bf1-d31078608018Product name120170609
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-3535-12022-02-03C16284748780-1d6a99b39-ccdb-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use BAVENCIO safely and effectively. See full prescribing information for BAVENCIO. BAVENCIO ® (avelumab) injection, for intravenous use Initial U.S. Approval: 2017
44087-3535-12022-01-28C16284748780-1d6a99b39-ccdb-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use BAVENCIO safely and effectively. See full prescribing information for BAVENCIO. BAVENCIO ® (avelumab) injection, for intravenous use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-3535-1BAVENCIO1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE123
44087-3535-1BAVENCIO10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-3535-1ML - Milliliter44087-353554e350d5-2eef-4be8-a603-142b2a968ded12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-3535BAVENCIO (AVELUMAB) INJECTION, SOLUTION, CONCENTRATE [EMD SERONO, INC.]22Current NDC, Legacy NDC, 2 package rows20250417_5cd725a1-2fa4-408a-a651-57a7b84b2118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1875542avelumab 200 MG in 10 ML InjectionPSN5cd725a1-2fa4-408a-a651-57a7b84b211823
1875547BAVENCIO 200 MG in 10 ML InjectionPSN5cd725a1-2fa4-408a-a651-57a7b84b211823
187554710 ML avelumab 20 MG/ML Injection [Bavencio]SBD5cd725a1-2fa4-408a-a651-57a7b84b211823
187554210 ML avelumab 20 MG/ML InjectionSCD5cd725a1-2fa4-408a-a651-57a7b84b211823
187554710 ML Bavencio 20 MG/ML InjectionSY5cd725a1-2fa4-408a-a651-57a7b84b211823
1875547Bavencio 200 MG per 10 ML InjectionSY5cd725a1-2fa4-408a-a651-57a7b84b211823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44087-3535-1440873535011 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSE2017-03-230000-00-00NoNoCurrent