FLUOROURACIL
- Product NDC
- 51862-362
- 11-digit product format
- 518620362
- Labeler code
- 51862
- Product ID
- 51862-362_d05a8a27-b7f9-40cc-a36a-97209fc998b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOROURACIL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA077524
- Marketing category
- ANDA
- Marketing start
- 2019-12-03
- 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 |
|---|
| 51862-362-40 | FLUOROURACIL | 1 in 1 CARTON | CREAM | 1 | | 3 |
| 51862-362-40 | FLUOROURACIL | 40 g in 1 TUBE | CREAM | 40 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-362 | FLUOROURACIL CREAM [MAYNE PHARMA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211106_06475bd8-66d9-4f88-90e4-b367480dab39.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 |
|---|
| 51862-362-40 | 51862036240 | 1 TUBE in 1 CARTON (51862-362-40) / 40 g in 1 TUBE | 1 tube | 2019-12-03 | 0000-00-00 | No | No | Current |