FLUOROURACIL
- Product NDC
- 75907-169
- 11-digit product format
- 759070169
- Labeler code
- 75907
- Product ID
- 75907-169_39a2cbc0-f588-5397-e063-6394a90a5390
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil Cream, 0.5%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- NDA020985
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-07-06
- Substance
- FLUOROURACIL
- Active strength
- 5 mg/g
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUOROURACIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROURACIL | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 284191 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75907-169-11 | FLUOROURACIL | 30 g in 1 TUBE | CREAM | 30 | | 1 |
| 75907-169-11 | FLUOROURACIL | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75907-169-11 | 75907016911 | 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE | 1 tube | 2025-07-06 | No | No | Current |