UNLOXCYT
- Product NDC
- 70095-130
- 11-digit product format
- 700950130
- Labeler code
- 70095
- Product ID
- 70095-130_4c6e425c-a8e7-4dde-b2b2-5ecc24b8a271
- 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
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UNLOXCYT
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COSIBELIMAB | 300 mg/5mL |
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 | 2026-09-01 |
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 |