NDC Code | 57894-505-05 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 57894-505 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Darzalex Iv |
Non-Proprietary Name | Daratumumab |
Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
Usage | INTRAVENOUS |
Start Marketing Date | 20211015 |
Marketing Category Name | BLA |
Application Number | BLA761036 |
Manufacturer | Janssen Biotech, Inc. |
Substance Name | DARATUMUMAB |
Strength | 100 |
Strength Unit | mg/5mL |
Pharmacy Classes | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC] |