Fluconazole
- Product NDC
- 68071-3515
- 11-digit product format
- 680713515
- Labeler code
- 68071
- Product ID
- 68071-3515_2bae5641-9af8-96cd-e063-6394a90ae348
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- Substance
- FLUCONAZOLE
- Active strength
- 150 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197699 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3515-2 | Fluconazole | 2 in 1 CARTON | TABLET | 2 | | 3 |
| 68071-3515-2 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 68071-3515-4 | Fluconazole | 4 in 1 CARTON | TABLET | 4 | | 3 |
| 68071-3515-4 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3515 | FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 4 package rows | 20250116_068623f9-0f87-50bc-e063-6294a90aea00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3515-2 | 68071351502 | 2 BLISTER PACK in 1 CARTON (68071-3515-2) / 1 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-09-29 | No | No | Historical |
| 68071-3515-4 | 68071351504 | 4 BLISTER PACK in 1 CARTON (68071-3515-4) / 1 TABLET in 1 BLISTER PACK | 4 blister pack | 2025-01-14 | No | No | Historical |