Fluconazole
- Product NDC
- 63629-8970
- 11-digit product format
- 636298970
- Labeler code
- 63629
- Product ID
- 63629-8970_f0a93e29-d92a-4f5c-835c-5cfd2e134f8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- 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
- 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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197701 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8970-1 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8970 | FLUCONAZOLE TABLET [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20241024_b94ca865-ab2f-466c-9913-dde9376e4533.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 |
|---|
| 63629-8970-1 | 63629897001 | 30 TABLET in 1 BOTTLE (63629-8970-1) | 30 tablet | 2024-10-08 | 0000-00-00 | No | No | Current |