unloxcyt

Generic: cosibelimab

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name unloxcyt
Generic Name cosibelimab
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cosibelimab 300 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 70095-130
Product ID 70095-130_32956dbc-6fe7-4e40-8496-cead92e453b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761297
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

Pharmacologic Class

Established (EPC)
programmed death ligand-1 blocker [epc]
Mechanism of Action
programmed death ligand-1 antagonists [moa] programmed death ligand-1-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70095130
Hyphenated Format 70095-130

Supplemental Identifiers

RxCUI
2717518 2717525
UNII
PNW7GBB44P
NUI
N0000193338 N0000193337 N0000193336 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name unloxcyt (source: ndc)
Generic Name cosibelimab (source: ndc)
Application Number BLA761297 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

70095-130-01 1 VIAL, GLASS in 1 CARTON (70095-130-01) / 5 mL in 1 VIAL, GLASS

Ingredients (1)

cosibelimab (300 mg/5mL)

Linked Drug Pages (1)

UNLOXCYT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "32956dbc-6fe7-4e40-8496-cead92e453b7", "openfda": {"nui": ["N0000193338", "N0000193337", "N0000193336", "M0001357"], "unii": ["PNW7GBB44P"], "rxcui": ["2717518", "2717525"], "spl_set_id": ["06bdadd5-d2db-406f-a3f8-de47f48a52e3"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["Programmed Death Ligand-1 Blocker [EPC]"], "pharm_class_moa": ["Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (70095-130-01)  / 5 mL in 1 VIAL, GLASS", "package_ndc": "70095-130-01", "marketing_start_date": "20251208"}], "brand_name": "UNLOXCYT", "product_id": "70095-130_32956dbc-6fe7-4e40-8496-cead92e453b7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1 Blocker [EPC]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"], "product_ndc": "70095-130", "generic_name": "cosibelimab", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UNLOXCYT", "active_ingredients": [{"name": "COSIBELIMAB", "strength": "300 mg/5mL"}], "application_number": "BLA761297", "marketing_category": "BLA", "marketing_start_date": "20251208", "listing_expiration_date": "20261231"}