KETOCONAZOLE
- Product NDC
- 50090-6142
- 11-digit product format
- 500906142
- Labeler code
- 50090
- Product ID
- 50090-6142_53e92009-965c-4487-9143-6ca9159893d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6142-1 | KETOCONAZOLE | 7 in 1 BOTTLE | TABLET | 7 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6142 | KETOCONAZOLE TABLET [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231102_517c29fc-2a2a-4bd5-a8bb-b464a65d2be0.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 |
|---|
| 50090-6142-1 | 50090614201 | 7 TABLET in 1 BOTTLE (50090-6142-1) | 7 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |