Efudex
- Product NDC
- 0187-3204
- 11-digit product format
- 001873204
- Labeler code
- 0187
- Product ID
- 0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA016831
- Marketing category
- NDA
- Marketing start
- 1970-07-29
- Substance
- FLUOROURACIL
- Active strength
- 2 g/40g
- 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
- Efudex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROURACIL | 2 g/40g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3P01618RT |
| Rxcui | 105583, 213045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-3204-47 | Efudex | 40 g in 1 TUBE | CREAM | 40 | | 20 |
| 0187-3204-47 | Efudex | 1 in 1 CARTON | CREAM | 1 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-3204 | EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [BAUSCH HEALTH US, LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250425_35de1c1c-bef5-46c5-b6f8-ea032147411c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-3204-47 | 00187320447 | 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE | 1 tube | 1970-07-29 | 2026-09-30 | No | No | Current |