Home NDC 50242-125 Columvi
Product NDC 50242-125
11-digit product format 502420125
Labeler code 50242
Product ID 50242-125_5e794f49-9344-4145-82e3-c2f7f96988c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glofitamab
Dosage form SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Genentech, Inc.
Application BLA761309
Marketing category BLA
Marketing start 2023-06-15
Substance GLOFITAMAB
Active strength 2.5 mg/2.5mL
Pharmacologic classes Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Columvi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLOFITAMAB 2.5 mg/2.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 06P3KLK2J8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639786 Internal RxNorm lookup 2639792 Internal RxNorm lookup 2639794 Internal RxNorm lookup 2639795 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 50242-125-01 Columvi 1 in 1 CARTON SOLUTION, CONCENTRATE 1 7 50242-125-01 Columvi 2.5 mL in 1 VIAL, SINGLE-DOSE SOLUTION, CONCENTRATE 2.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-125 COLUMVI (GLOFITAMAB) CONCENTRATE COLUMVI (GLOFITAMAB) SOLUTION, CONCENTRATE [GENENTECH, INC.] 5 Current NDC, 2 package rows 20250108_3516e753-f064-4d30-9bd5-e3f2e143f75d.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761309 Columvi glofitamab-gxbm 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 Sample Exclude flag Status 50242-125-01 50242012501 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE 2023-06-15 No No Current