| Product NDC: | 63323-117 |
| Proprietary Name: | Fluorouracil |
| Non Proprietary Name: | FLUOROURACIL |
| Active Ingredient(s): | 50 mg/mL & nbsp; FLUOROURACIL |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-117 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040278 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20000712 |
| Package NDC: | 63323-117-20 |
| Package Description: | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20) > 20 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63323-117-20 |
| Proprietary Name | Fluorouracil |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20) > 20 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63323-117 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | FLUOROURACIL |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20000712 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | FLUOROURACIL |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |