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NDC 67457-0546-20 clofarabine 1 mg/mL Details
clofarabine 1 mg/mL
clofarabine is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is CLOFARABINE.
MedlinePlus Drug Summary
Clofarabine is used to treat acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in children and young adults 1 to 21 years old who have already received at least two other treatments. Clofarabine is in a class of medications called purine nucleoside antimetabolites. It works by killing existing cancer cells and limiting the development of new cancer cells.
Related Packages: 67457-0546-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Clofarabine Injection
Product Information
| NDC | 67457-0546 |
|---|---|
| Product ID | 67457-546_2a7d705c-2339-4515-9679-083f9bc24938 |
| Associated GPIs | 21300008002020 |
| GCN Sequence Number | 058571 |
| GCN Sequence Number Description | clofarabine VIAL 20 MG/20ML INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 24037 |
| HICL Sequence Number | 026816 |
| HICL Sequence Number Description | CLOFARABINE |
| Brand/Generic | Generic |
| Proprietary Name | clofarabine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | clofarabine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | CLOFARABINE |
| Labeler Name | Mylan Institutional LLC |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208860 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0546-20 (67457054620)
| NDC Package Code | 67457-546-20 |
|---|---|
| Billing NDC | 67457054620 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2017-11-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |