Febuxostat
- Product NDC
- 0378-3926
- 11-digit product format
- 003783926
- Labeler code
- 0378
- Product ID
- 0378-3926_3f5600cd-1f2f-410a-8c55-b8363d4fc492
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205385
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Marketing end
- 0000-00-00
- Substance
- FEBUXOSTAT
- Active strength
- 80 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-3926-93 | 00378392693 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3926-93) | 2019-07-01 | 0000-00-00 | No | No | Current |