Home NDC 0069-2522 Elrexfio
Product NDC 0069-2522
11-digit product format 000692522
Labeler code 0069
Product ID 0069-2522_0835fd76-fbb7-49aa-99bc-2a29e35c5252
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name elranatamab-bcmm
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Pfizer Laboratories Div Pfizer Inc
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Elrexfio
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELRANATAMAB 44 mg/1.1mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-2522-01 Elrexfio 1.1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1.1 4 0069-2522-02 Elrexfio 1 in 1 CARTON INJECTION, SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-2522 ELREXFIO (ELRANATAMAB-BCMM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 1 Current NDC, 2 package rows 20230817_f6fea598-ff58-4a20-b5e8-8a51f37d8beb.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Elrexfio ELRANATAMAB-BCMM U.S. Pharmaceuticals aa044060-5b4b-4692-bf0f-9a50e140b10e 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761345
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761345 Elrexfio elranatamab-bcmm 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-2522-01 00069252201 1.1 mL in 1 VIAL, SINGLE-DOSE 1.1 ml Historical 0069-2522-02 00069252202 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-2522-02) / 1.1 mL in 1 VIAL, SINGLE-DOSE (0069-2522-01) 2023-08-15 No No Current