FDA.reportPublic FDA data

Elrexfio

Product NDC
63539-252
11-digit product format
635390252
Labeler code
63539
Product ID
63539-252_e5f013ba-4382-4ce2-8650-2ce23a5aaa5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elranatamab-bcmm
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
U.S. Pharmaceuticals
Application
BLA761345
Marketing category
BLA
Marketing start
2023-08-15
Substance
ELRANATAMAB
Active strength
44 mg/1.1mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElrexfioELRANATAMAB-BCMMU.S. Pharmaceuticalsaa044060-5b4b-4692-bf0f-9a50e140b10e2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761345
ndc (product): 63539-252
ElrexfioELRANATAMAB-BCMMPfizer Laboratories Div Pfizer Incf6fea598-ff58-4a20-b5e8-8a51f37d8beb2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761345

Additional Listing Data#

Finished product
Yes
Brand name base
Elrexfio
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELRANATAMAB44 mg/1.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L0HR9A577VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644885Internal RxNorm lookup
2644891Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa044060-5b4b-4692-bf0f-9a50e140b10eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf04f12d-3435-41d4-973b-e759446596f3Product name120241008
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-252-01Elrexfio1.1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1.15
63539-252-02Elrexfio1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-252ELREXFIO (ELRANATAMAB-BCMM) INJECTION, SOLUTION [U.S. PHARMACEUTICALS]1Current NDC, 2 package rows20230817_aa044060-5b4b-4692-bf0f-9a50e140b10e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761345Elrexfioelranatamab-bcmm351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644885elranatamab-bcmm 44 MG in 1.1 ML InjectionPSNaa044060-5b4b-4692-bf0f-9a50e140b10e5
2644891ELREXFIO 44 MG in 1.1 ML InjectionPSNaa044060-5b4b-4692-bf0f-9a50e140b10e5
26448911.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]SBDaa044060-5b4b-4692-bf0f-9a50e140b10e5
26448851.1 ML elranatamab-bcmm 40 MG/ML InjectionSCDaa044060-5b4b-4692-bf0f-9a50e140b10e5
26448911.1 ML Elrexfio 40 MG/ML InjectionSYaa044060-5b4b-4692-bf0f-9a50e140b10e5
2644885elranatamab-bcmm 44 MG per 1.1 ML InjectionSYaa044060-5b4b-4692-bf0f-9a50e140b10e5
2644891Elrexfio 44 MG per 1.1 ML InjectionSYaa044060-5b4b-4692-bf0f-9a50e140b10e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63539-252-01635390252011.1 mL in 1 VIAL, SINGLE-DOSE1.1 mlHistorical
63539-252-02635390252021 VIAL, SINGLE-DOSE in 1 CARTON (63539-252-02) / 1.1 mL in 1 VIAL, SINGLE-DOSE (63539-252-01) 2023-08-15YesNoCurrent