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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KXG2PJ551IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1875542Internal RxNorm lookup
1875547Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5cd725a1-2fa4-408a-a651-57a7b84b2118Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BAVENCIOAVELUMABEMD Serono, Inc.5cd725a1-2fa4-408a-a651-57a7b84b21182025-06-13Warnings, Adverse reactionsExact identifier
application number: BLA761049
ndc (product): 44087-3535

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761049Bavencioavelumab351(a)Rx2026-06-01

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