Home NDC 50242-127 Columvi
Product NDC 50242-127
11-digit product format 502420127
Labeler code 50242
Product ID 50242-127_5e794f49-9344-4145-82e3-c2f7f96988c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glofitamab
Dosage form CONCENTRATE
Route INTRAVENOUS
Labeler Genentech, Inc.
Application BLA761309
Marketing category BLA
Marketing start 2023-06-15
Substance GLOFITAMAB
Active strength 10 mg/10mL
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 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Columvi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLOFITAMAB 10 mg/10mL
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 50242-127-01 Columvi 1 in 1 CARTON CONCENTRATE 1 7 50242-127-01 Columvi 10 mL in 1 VIAL, SINGLE-DOSE CONCENTRATE 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-127 COLUMVI (GLOFITAMAB) CONCENTRATE COLUMVI (GLOFITAMAB) SOLUTION, CONCENTRATE [GENENTECH, INC.] 5 Current NDC, 2 package rows 20250108_3516e753-f064-4d30-9bd5-e3f2e143f75d.zip
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 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50242-127-01 50242012701 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-06-15 No No Current