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NDC 57894-0505-20 Darzalex IV 100 mg/5mL Details
Darzalex IV 100 mg/5mL
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.
MedlinePlus Drug Summary
Daratumumab injection is used alone or in combination with other medications to treat multiple myeloma (a type of cancer of the bone marrow) in newly diagnosed people and in people who have not improved with treatment or who have improved after treatment with other medications but the condition returned. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
Related Packages: 57894-0505-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Daratumumab Injection
Product Information
| NDC | 57894-0505 |
|---|---|
| Product ID | 57894-505_0aac2082-de78-31cb-e063-6394a90a5b78 |
| Associated GPIs | |
| GCN Sequence Number | 075163 |
| GCN Sequence Number Description | daratumumab VIAL 100 MG/5ML INTRAVEN |
| HIC3 | V3V |
| HIC3 Description | ANTINEOPLASTIC - ANTI-CD38 MONOCLONAL ANTIBODY |
| GCN | 40156 |
| HICL Sequence Number | 042814 |
| HICL Sequence Number Description | DARATUMUMAB |
| Brand/Generic | Brand |
| Proprietary Name | Darzalex IV |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Daratumumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DARATUMUMAB |
| Labeler Name | Janssen Biotech, Inc. |
| Pharmaceutical Class | Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761036 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0505-20 (57894050520)
| NDC Package Code | 57894-505-20 |
|---|---|
| Billing NDC | 57894050520 |
| Package | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2021-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |