Fluconazole
- Product NDC
- 0054-0002
- 11-digit product format
- 000540002
- Labeler code
- 0054
- Product ID
- 0054-0002_1b6247a8-20f5-4ed0-a504-3bdd3e4e3d3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA076246
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- Marketing end
- 2021-05-31
- Substance
- FLUCONAZOLE
- Active strength
- 10 mg/mL
- 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
- 0000-00-00
- 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 |
|---|
| 0054-0002-85 | 00054000285 | 350 mL in 1 BOTTLE, PLASTIC (0054-0002-85) | 350 ml | 2004-07-29 | 2021-05-31 | No | No | Current |