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

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

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 · 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761345Elrexfioelranatamab-bcmm351(a)Rx2026-08-01

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