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 |