Ketoconazole
- Product NDC
- 70685-001
- 11-digit product format
- 706850001
- Labeler code
- 70685
- Product ID
- 70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Esjay Pharma LLC
- Application
- ANDA219129
- Marketing category
- ANDA
- Marketing start
- 2025-09-10
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70685-001-01 | Ketoconazole | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 70685-001-02 | Ketoconazole | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 70685-001-03 | Ketoconazole | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70685-001-01 | 70685000101 | 30 TABLET in 1 BOTTLE (70685-001-01) | 30 tablet | 2025-09-10 | No | No | Current |
| 70685-001-02 | 70685000102 | 100 TABLET in 1 BOTTLE (70685-001-02) | 100 tablet | 2025-09-10 | No | No | Current |
| 70685-001-03 | 70685000103 | 500 TABLET in 1 BOTTLE (70685-001-03) | 500 tablet | 2025-09-10 | No | No | Current |