Fluconazole
- Product NDC
- 0904-6500
- 11-digit product format
- 009046500
- Labeler code
- 0904
- Product ID
- 0904-6500_3c6a1b79-df4e-4281-959e-8f41c97b13c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076658
- Marketing category
- ANDA
- Marketing start
- 2015-06-25
- Substance
- FLUCONAZOLE
- Active strength
- 100 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698, 197700 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6500-06 | Fluconazole | 50 in 1 CARTON | TABLET | 50 | | 8 |
| 0904-6500-06 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
| 0904-6500-61 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
| 0904-6500-61 | Fluconazole | 100 in 1 CARTON | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6500 | FLUCONAZOLE TABLET [MAJOR PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250104_13184b13-e252-4b4d-a3e2-cfc4ad3d55b7.zip |
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 |
|---|
| 0904-6500-06 | 00904650006 | 50 BLISTER PACK in 1 CARTON (0904-6500-06) / 1 TABLET in 1 BLISTER PACK | 50 blister pack | 2015-06-25 | 0000-00-00 | No | No | Current |
| 0904-6500-61 | 00904650061 | 100 BLISTER PACK in 1 CARTON (0904-6500-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2015-06-25 | 0000-00-00 | No | No | Current |