NDC 57894-505
Darzalex IV
Daratumumab
Darzalex IV is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Daratumumab.
| Product ID | 57894-505_13e6e5d9-5afd-409f-956f-6587d8c1fbe7 |
| NDC | 57894-505 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Darzalex IV |
| Generic Name | Daratumumab |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2021-10-15 |
| Marketing Category | BLA / |
| Application Number | BLA761036 |
| Labeler Name | Janssen Biotech, Inc. |
| Substance Name | DARATUMUMAB |
| Active Ingredient Strength | 100 mg/5mL |
| Pharm Classes | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |