Fluorouracil
- Product NDC
- 16714-178
- 11-digit product format
- 167140178
- Labeler code
- 16714
- Product ID
- 16714-178_7106b404-bb4d-43e4-9809-17bd2e95a63b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA090368
- Marketing category
- ANDA
- Marketing start
- 2010-03-05
- 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 |
|---|
| 16714-178-01 | Fluorouracil | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 16714-178-01 | 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 |
|---|
| 16714-178 | FLUOROURACIL CREAM [NORTHSTAR RX LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211212_52ef5f41-2312-4b55-aa86-abd5bb28b9d3.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 |
|---|
| 16714-178-01 | 16714017801 | 1 TUBE in 1 CARTON (16714-178-01) / 40 g in 1 TUBE | 1 tube | 2021-11-30 | 0000-00-00 | No | No | Current |