fluconazole
- Product NDC
- 70710-1137
- 11-digit product format
- 707101137
- Labeler code
- 70710
- Product ID
- 70710-1137_538304da-3971-4e3d-9ad3-af8b3dc186c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA208963
- Marketing category
- ANDA
- Marketing start
- 2017-04-06
- Substance
- FLUCONAZOLE
- Active strength
- 50 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698, 197699, 197700, 197701 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1137 | FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 12 | Current NDC, Legacy NDC, 5 package rows | 20240306_d1364455-1537-46d4-b093-38cca3be778f.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 |
|---|
| 70710-1137-1 | 70710113701 | 100 TABLET in 1 BOTTLE (70710-1137-1) | 100 tablet | 2017-04-06 | 0000-00-00 | No | No | Current |
| 70710-1137-3 | 70710113703 | 30 TABLET in 1 BOTTLE (70710-1137-3) | 30 tablet | 2017-04-06 | 0000-00-00 | No | No | Current |
| 70710-1137-4 | 70710113704 | 10 BLISTER PACK in 1 CARTON (70710-1137-4) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-04-06 | 0000-00-00 | No | No | Current |
| 70710-1137-5 | 70710113705 | 500 TABLET in 1 BOTTLE (70710-1137-5) | 500 tablet | 2017-04-06 | 0000-00-00 | No | No | Current |