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NDC 68001-0524-31 Fluorouracil 50 mg/mL Details
Fluorouracil 50 mg/mL
Fluorouracil is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is FLUOROURACIL.
MedlinePlus Drug Summary
Fluorouracil is generally used in combination with other medications to treat colon cancer or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. Fluorouracil is used in combination with other medications to treat certain types of breast cancer after surgery to remove the tumor or radiation therapy. Fluorouracil is also used to treat cancer of the pancreas and stomach cancer. Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in your body.
Related Packages: 68001-0524-31Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluorouracil Injection
Product Information
| NDC | 68001-0524 |
|---|---|
| Product ID | 68001-524_08b153f7-c264-c73d-e063-6394a90ac32c |
| Associated GPIs | 21300030002020 21300030002025 |
| GCN Sequence Number | 061669 |
| GCN Sequence Number Description | fluorouracil VIAL 500MG/10ML INTRAVEN |
| HIC3 | V1B |
| HIC3 Description | ANTINEOPLASTIC - ANTIMETABOLITES |
| GCN | 97455 |
| HICL Sequence Number | 003907 |
| HICL Sequence Number Description | FLUOROURACIL |
| Brand/Generic | Generic |
| Proprietary Name | Fluorouracil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluorouracil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUOROURACIL |
| Labeler Name | BluePoint Laboratories |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210123 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68001-0524-31 (68001052431)
| NDC Package Code | 68001-524-31 |
|---|---|
| Billing NDC | 68001052431 |
| Package | 10 VIAL in 1 CARTON (68001-524-31) / 20 mL in 1 VIAL (68001-524-29) |
| Marketing Start Date | 2022-02-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |