Fluconazole
- Product NDC
- 0172-5413
- 11-digit product format
- 001725413
- Labeler code
- 0172
- Product ID
- 0172-5413_27a18adf-4a27-479c-bd3c-a58938662ee1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076077
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- Marketing end
- 2022-06-30
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FLUCONAZOLE TABLET [STAT RX USA LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FLUCONAZOLE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0172-5413-46 | 00172541346 | 30 TABLET in 1 BOTTLE (0172-5413-46) | 30 tablet | 2004-07-29 | 2022-06-30 | No | No | Current |
| 0172-5413-60 | 00172541360 | 100 TABLET in 1 BOTTLE (0172-5413-60) | 100 tablet | 2004-07-29 | 0000-00-00 | No | No | Current |