KETOCONAZOLE
- Product NDC
- 71335-1849
- 11-digit product format
- 713351849
- Labeler code
- 71335
- Product ID
- 71335-1849_e44810bf-246c-4043-bd20-28f512e0e347
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075912
- Marketing category
- ANDA
- Marketing start
- 2020-04-10
- Substance
- KETOCONAZOLE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein 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
- KETOCONAZOLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 197853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1849 | KETOCONAZOLE TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 8 package rows | 20240524_3ea8a22b-cd61-4623-a11f-43e3396b50fa.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 |
|---|
| 71335-1849-1 | 71335184901 | 10 TABLET in 1 BOTTLE (71335-1849-1) | 10 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-2 | 71335184902 | 30 TABLET in 1 BOTTLE (71335-1849-2) | 30 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-3 | 71335184903 | 40 TABLET in 1 BOTTLE (71335-1849-3) | 40 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-4 | 71335184904 | 60 TABLET in 1 BOTTLE (71335-1849-4) | 60 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-5 | 71335184905 | 8 TABLET in 1 BOTTLE (71335-1849-5) | 8 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-6 | 71335184906 | 7 TABLET in 1 BOTTLE (71335-1849-6) | 7 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-7 | 71335184907 | 14 TABLET in 1 BOTTLE (71335-1849-7) | 14 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |
| 71335-1849-8 | 71335184908 | 90 TABLET in 1 BOTTLE (71335-1849-8) | 90 tablet | 2021-12-21 | 0000-00-00 | No | No | Current |