FLUOROURACIL
- Product NDC
- 75907-095
- 11-digit product format
- 759070095
- Labeler code
- 75907
- Product ID
- 75907-095_984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOROURACIL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dr. Reddy's Labratories Inc.
- Application
- ANDA077524
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- Substance
- FLUOROURACIL
- Active strength
- 50 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 | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 105583 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75907-095-40 | FLUOROURACIL | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 75907-095-40 | FLUOROURACIL | 40 g in 1 TUBE | CREAM | 40 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75907-095 | FLUOROURACIL CREAM [DR. REDDY'S LABRATORIES INC.] | 1 | Current NDC, 2 package rows | 20240415_e137c766-1f7f-0251-90b9-450c3d4d78b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75907-095-40 | 75907009540 | 1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE | 1 tube | 2024-04-15 | No | No | Historical |