Fluorouracil is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Fluorouracil.
| Product ID | 68083-269_4b57432f-c80b-4f87-87e7-4ec0c246f848 |
| NDC | 68083-269 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluorouracil |
| Generic Name | Fluorouracil |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-11-07 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210123 |
| Labeler Name | Gland Pharma Limited |
| Substance Name | FLUOROURACIL |
| Active Ingredient Strength | 50 mg/mL |
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-11-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-11-07 |
| Marketing Category | ANDA |
| Application Number | ANDA210123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-11-07 |
| Ingredient | Strength |
|---|---|
| FLUOROURACIL | 50 mg/mL |
| SPL SET ID: | 572b710e-8e2b-46eb-bd80-648ad769d34d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-4791 | Fluorouracil | Fluorouracil |
| 16714-178 | Fluorouracil | Fluorouracil |
| 16729-276 | Fluorouracil | Fluorouracil |
| 16729-542 | Fluorouracil | Fluorouracil |
| 21695-829 | FLUOROURACIL | fluorouracil |
| 25021-215 | fluorouracil | fluorouracil |
| 68001-266 | Fluorouracil | Fluorouracil |
| 68083-293 | Fluorouracil | Fluorouracil |
| 68083-292 | Fluorouracil | Fluorouracil |
| 68083-269 | Fluorouracil | Fluorouracil |
| 68083-270 | Fluorouracil | Fluorouracil |
| 43547-259 | Fluorouracil | Fluorouracil |
| 43547-258 | Fluorouracil | Fluorouracil |
| 51672-4063 | Fluorouracil | Fluorouracil |
| 51672-4062 | Fluorouracil | Fluorouracil |
| 51672-4118 | Fluorouracil | Fluorouracil |
| 52549-4118 | Fluorouracil | Fluorouracil |
| 63323-117 | Fluorouracil | Fluorouracil |
| 66758-044 | Fluorouracil | Fluorouracil |
| 66758-054 | Fluorouracil | Fluorouracil |
| 66530-249 | FLUOROURACIL | FLUOROURACIL |
| 66530-258 | Fluorouracil | Fluorouracil |
| 50090-4264 | Fluorouracil | Fluorouracil |
| 51862-362 | FLUOROURACIL | FLUOROURACIL |
| 50742-483 | FLUOROURACIL | FLUOROURACIL |
| 50742-481 | FLUOROURACIL | FLUOROURACIL |
| 50742-423 | FLUOROURACIL | FLUOROURACIL |
| 50742-482 | FLUOROURACIL | FLUOROURACIL |
| 0703-3015 | Adrucil | Fluorouracil |
| 0703-3018 | Adrucil | Fluorouracil |
| 0703-3019 | Adrucil | Fluorouracil |
| 0187-5200 | Carac | fluorouracil |
| 0187-3204 | Efudex | Fluorouracil |
| 16110-812 | Fluoroplex | fluorouracil |
| 0378-8078 | Fluorouracil Cream | fluorouracil |