Fluorouracil Cream
- Product NDC
- 0378-8078
- 11-digit product format
- 003788078
- Labeler code
- 0378
- Product ID
- 0378-8078_8c0b453a-7e42-4edf-9e86-7cc2297a2354
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorouracil
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020985
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-08-28
- Marketing end
- 0000-00-00
- Substance
- FLUOROURACIL
- Active strength
- 5 mg/g
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8078-49 | 00378807849 | 1 TUBE in 1 CARTON (0378-8078-49) > 30 g in 1 TUBE | 1 tube | 2020-08-28 | 0000-00-00 | No | No | Current |