Fluorouracil
- Product NDC
- 16729-542
- 11-digit product format
- 167290542
- Labeler code
- 16729
- Product ID
- 16729-542_23a8557b-45e6-e3cf-e063-6394a90a4b0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA214845
- Marketing category
- ANDA
- Marketing start
- 2021-11-11
- 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 |
|---|
| 16729-542-35 | Fluorouracil | 1 in 1 CARTON | CREAM | 1 | | 5 |
| 16729-542-35 | Fluorouracil | 40 g in 1 TUBE | CREAM | 40 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-542 | FLUOROURACIL CREAM [ACCORD HEALTHCARE INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241006_667d4059-de90-4d3f-86c2-c2573def2ecb.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 |
|---|
| 16729-542-35 | 16729054235 | 1 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBE | 1 tube | 2021-11-11 | 0000-00-00 | No | No | Current |