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NDC 49315-0003-06 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 Zydus Lifesciences Limited. 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: 49315-0003-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Clofarabine Injection
Product Information
| NDC | 49315-0003 |
|---|---|
| Product ID | 49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | Zydus Lifesciences Limited |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204029 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49315-0003-06 (49315000306)
| NDC Package Code | 49315-003-06 |
|---|---|
| Billing NDC | 49315000306 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2017-05-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4d8d8e81-01ba-4493-b458-7f6375c5bbae Details
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| CLOFARABINE
clofarabine injection |
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| Labeler - Zydus Lifesciences Limited (650348852) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Zydus Lifesciences Limited | 650348852 | ANALYSIS(49315-003) , MANUFACTURE(49315-003) | |
Revised: 10/2022
Document Id: a6a1f86a-61c0-4769-8f6a-2b7af01c1410
Set id: 4d8d8e81-01ba-4493-b458-7f6375c5bbae
Version: 2
Effective Time: 20221018