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 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
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 761297 Unloxcyt cosibelimab-ipdl 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 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