FDA.reportPublic FDA data

Blenrep

Product NDC
0173-0913
11-digit product format
001730913
Labeler code
0173
Product ID
0173-0913_aef7c34c-fef8-407c-99c0-a68aded53c60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
belantamab mafodotin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
GlaxoSmithKline LLC
Application
BLA761440
Marketing category
BLA
Marketing start
2025-10-23
Substance
BELANTAMAB MAFODOTIN
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BELANTAMAB MAFODOTIN50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DB1041CXDGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725585Internal RxNorm lookup
2725587Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aef7c34c-fef8-407c-99c0-a68aded53c60Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5c7649c1-d119-44ba-bcf7-04410d2468aeProduct name120210225

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0913-01Blenrep1.4 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1.41
0173-0913-01Blenrep1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0913-01EA - Each0173-09136d751534-fa58-4b10-83ad-ad7cd6b66bf412025-11-13

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
BlenrepBELANTAMAB MAFODOTINGlaxoSmithKline LLCaef7c34c-fef8-407c-99c0-a68aded53c602025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761440
ndc (product): 0173-0913

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761440Blenrepbelantamab mafodotin-blmf351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725585belantamab mafodotin-blmf 70 MG InjectionPSNaef7c34c-fef8-407c-99c0-a68aded53c601
2725587BLENREP 70 MG InjectionPSNaef7c34c-fef8-407c-99c0-a68aded53c601
2725587belantamab mafodotin-blmf 70 MG Injection [Blenrep]SBDaef7c34c-fef8-407c-99c0-a68aded53c601
2725585belantamab mafodotin-blmf 70 MG InjectionSCDaef7c34c-fef8-407c-99c0-a68aded53c601
2725587Blenrep 70 MG InjectionSYaef7c34c-fef8-407c-99c0-a68aded53c601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0173-0913-01001730913011 VIAL in 1 CARTON (0173-0913-01) / 1.4 mL in 1 VIAL1 vial2025-10-23NoNoCurrent