Fluconazole
- Product NDC
- 70985-013
- 11-digit product format
- 709850013
- Labeler code
- 70985
- Product ID
- 70985-013_eb51cf40-8e0c-3478-e053-2995a90ac6e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Drug Ocean LLC
- Application
- ANDA076957
- Marketing category
- ANDA
- Marketing start
- 2021-06-26
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70985-013 | FLUCONAZOLE TABLET [DRUG OCEAN LLC] | 14 | Legacy NDC | 20241118_c5bfc182-b35f-afc4-e053-2a95a90ae5c3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70985-013-01 | 70985001301 | 100 TABLET in 1 BOTTLE (70985-013-01) | 100 tablet | 2021-06-26 | 0000-00-00 | No | No | Current |
| 70985-013-03 | 70985001303 | 30 TABLET in 1 BOTTLE (70985-013-03) | 30 tablet | 2021-06-26 | 0000-00-00 | No | No | Current |