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NDC 66302-0014-01 Unituxin 3.5 mg/mL Details
Unituxin 3.5 mg/mL
Unituxin is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by United Therapeutics Corporation. The primary component is DINUTUXIMAB.
MedlinePlus Drug Summary
Dinutuximab injection is used in combination with other medications to treat neuroblastoma (a cancer that begins in nerve cells) in children who have responded to other treatments. Dinutuximab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.
Related Packages: 66302-0014-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dinutuximab Injection
Product Information
| NDC | 66302-0014 |
|---|---|
| Product ID | 66302-014_292edc42-e0de-40b2-be38-aadc411b1c88 |
| Associated GPIs | 21356028002020 |
| GCN Sequence Number | 074093 |
| GCN Sequence Number Description | dinutuximab VIAL 3.5 MG/ML INTRAVEN |
| HIC3 | V1K |
| HIC3 Description | ANTINEOPLASTICS ANTIBODY/ANTIBODY-DRUG COMPLEXES |
| GCN | 38638 |
| HICL Sequence Number | 042038 |
| HICL Sequence Number Description | DINUTUXIMAB |
| Brand/Generic | Brand |
| Proprietary Name | Unituxin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DINUTUXIMAB |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 3.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | DINUTUXIMAB |
| Labeler Name | United Therapeutics Corporation |
| Pharmaceutical Class | Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125516 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66302-0014-01 (66302001401)
| NDC Package Code | 66302-014-01 |
|---|---|
| Billing NDC | 66302001401 |
| Package | 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2015-03-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |