Fluconazole
- Product NDC
- 52343-086
- 11-digit product format
- 523430086
- Labeler code
- 52343
- Product ID
- 52343-086_a3a4f8db-a312-4c4d-b873-119ed4973bf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ACETRIS HEALTH, LLC
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52343-086-01 | 52343008601 | 100 TABLET in 1 BOTTLE (52343-086-01) | 100 tablet | 2008-10-07 | 0000-00-00 | No | No | Current |