Fluconazole
- Product NDC
- 53002-1198
- 11-digit product format
- 530021198
- Labeler code
- 53002
- Product ID
- 53002-1198_c1e1a93a-ff95-44c5-bf21-d5c16b6bd90f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2017-02-24
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 150 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 8VZV102JFY | FLUCONAZOLE | 86386-73-4 | FLUCONAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1198-1 | 53002119801 | 1 TABLET in 1 BLISTER PACK (53002-1198-1) | 1 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1198-2 | 53002119802 | 2 TABLET in 1 BLISTER PACK (53002-1198-2) | 2 tablet | 2017-09-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets, USP | RPK Pharmaceuticals, Inc. | 2020-12-15 | HUMAN PRESCRIPTION DRUG LABEL | 5 |