Fluconazole
- Product NDC
- 51655-889
- 11-digit product format
- 516550889
- Labeler code
- 51655
- Product ID
- 51655-889_49740b5f-0ca9-2aa7-e063-6394a90a36e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2023-02-15
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-889-07 | Fluconazole | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-889 | FLUCONAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20240810_f76bf2f7-1752-7656-e053-6394a90a8d22.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 |
|---|
| 51655-889-07 | 51655088907 | 7 TABLET in 1 BOTTLE, PLASTIC (51655-889-07) | 7 tablet | 2023-02-15 | No | No | Current |