Fluorouracil
- Product NDC
- 68001-524
- 11-digit product format
- 680010524
- Labeler code
- 68001
- Product ID
- 68001-524_4bbe764b-4bfd-3862-e063-6394a90a7cc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA210123
- Marketing category
- ANDA
- Marketing start
- 2022-02-18
- Substance
- FLUOROURACIL
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U3P01618RT | FLUOROURACIL | 51-21-8 | FLUOROURACIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-524-30 | 68001052430 | 10 VIAL in 1 CARTON (68001-524-30) / 10 mL in 1 VIAL (68001-524-28) | 10 vial | 2022-02-18 | No | No | Historical |
| 68001-524-31 | 68001052431 | 10 VIAL in 1 CARTON (68001-524-31) / 20 mL in 1 VIAL (68001-524-29) | 10 vial | 2022-02-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluorouracil | BluePoint Laboratories | Gland Pharma Limited | 2026-02-26 | HUMAN PRESCRIPTION DRUG LABEL | 5 |