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NDC 59923-0604-02 Fludarabine Phosphate 25 mg/mL Details
Fludarabine Phosphate 25 mg/mL
Fludarabine Phosphate is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Areva Pharmaceuticals. The primary component is FLUDARABINE PHOSPHATE.
MedlinePlus Drug Summary
Fludarabine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells) in adults who have already been treated with at least one other medication and have not gotten better. Fludarabine injection is in a class of medications called purine analogs. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 59923-0604-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fludarabine Injection
Product Information
| NDC | 59923-0604 |
|---|---|
| Product ID | 59923-604_f4b6988f-58a9-4593-e053-2a95a90afe36 |
| Associated GPIs | 21300025102020 |
| GCN Sequence Number | 058106 |
| GCN Sequence Number Description | fludarabine phosphate VIAL 50 MG/2 ML INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 23439 |
| HICL Sequence Number | 006308 |
| HICL Sequence Number Description | FLUDARABINE PHOSPHATE |
| Brand/Generic | Generic |
| Proprietary Name | Fludarabine Phosphate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fludarabine Phosphate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUDARABINE PHOSPHATE |
| Labeler Name | Areva Pharmaceuticals |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090724 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59923-0604-02 (59923060402)
| NDC Package Code | 59923-604-02 |
|---|---|
| Billing NDC | 59923060402 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2019-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |