Home NDC 70095-130 UNLOXCYT
Product NDC 70095-130
11-digit product format 700950130
Labeler code 70095
Product ID 70095-130_32956dbc-6fe7-4e40-8496-cead92e453b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cosibelimab
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application BLA761297
Marketing category BLA
Marketing start 2025-12-08
Substance COSIBELIMAB
Active strength 300 mg/5mL
Pharmacologic classes Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
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 UNLOXCYT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COSIBELIMAB 300 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PNW7GBB44P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2717518 Internal RxNorm lookup 2717525 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 70095-130-01 UNLOXCYT 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 3 70095-130-01 UNLOXCYT 1 in 1 CARTON INJECTION, SOLUTION 1 3
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761297 Unloxcyt cosibelimab-ipdl 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 70095-130-01 70095013001 1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS 2025-12-08 No No Current