Home NDC 72903-853 ELAHERE
Product NDC 72903-853
11-digit product format 729030853
Labeler code 72903
Product ID 72903-853_47f1c78d-c469-4cd7-926e-51ce5b2d26f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIRVETUXIMAB SORAVTANSINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ImmunoGen, Inc.
Application BLA761310
Marketing category BLA
Marketing start 2022-11-14
Substance MIRVETUXIMAB SORAVTANSINE
Active strength 5 mg/mL
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 ELAHERE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIRVETUXIMAB SORAVTANSINE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98DE7VN88D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2621553 Internal RxNorm lookup 2621559 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72903-853-01 ELAHERE 1 in 1 CARTON INJECTION, SOLUTION 1 14 72903-853-01 ELAHERE 20 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 20 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72903-853 ELAHERE (MIRVETUXIMAB SORAVTANSINE) INJECTION, SOLUTION [IMMUNOGEN, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241101_00c424b5-6ccd-48ab-9e88-1986451120e2.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 ELAHERE MIRVETUXIMAB SORAVTANSINE ImmunoGen, Inc. 00c424b5-6ccd-48ab-9e88-1986451120e2 2025-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761310 ndc (product): 72903-853
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761310 Elahere mirvetuximab soravtansine-gynx 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72903-853-01 72903085301 1 VIAL, SINGLE-USE in 1 CARTON (72903-853-01) / 20 mL in 1 VIAL, SINGLE-USE 2022-11-14 0000-00-00 No No Current