Fluconazole
- Product NDC
- 16714-691
- 11-digit product format
- 167140691
- Labeler code
- 16714
- Product ID
- 16714-691_06bbf63a-4457-4206-af05-246be0ddb301
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698, 197699, 197700, 197701 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-691-01 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | | 19 |
| 16714-691-02 | Fluconazole | 100 in 1 BOTTLE | TABLET | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-691 | FLUCONAZOLE TABLET [NORTHSTAR RX LLC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240809_d2acccda-8068-46c1-8562-950d7f70ee06.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 |
|---|
| 16714-691-01 | 16714069101 | 30 TABLET in 1 BOTTLE (16714-691-01) | 30 tablet | 2008-10-07 | 0000-00-00 | No | No | Current |
| 16714-691-02 | 16714069102 | 100 TABLET in 1 BOTTLE (16714-691-02) | 100 tablet | 2008-10-07 | 0000-00-00 | No | No | Current |