Fluconazole
- Product NDC
- 72189-516
- 11-digit product format
- 721890516
- Labeler code
- 72189
- Product ID
- 72189-516_2c4e6424-181d-1db8-e063-6294a90a52d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2023-10-05
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197700 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-516-03 | Fluconazole | 3 in 1 BOTTLE | TABLET | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-516 | FLUCONAZOLE TABLET [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_06f8f4b9-5289-2d59-e063-6294a90a7209.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 |
|---|
| 72189-516-03 | 72189051603 | 3 TABLET in 1 BOTTLE (72189-516-03) | 3 tablet | 2023-10-05 | No | No | Current |