Ketoconazole
- Product NDC
- 72189-428
- 11-digit product format
- 721890428
- Labeler code
- 72189
- Product ID
- 72189-428_2c4d6606-d6a7-0085-e063-6294a90acaa2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA075319
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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 |
|---|
| 72189-428-07 | Ketoconazole | 7 in 1 BOTTLE | TABLET | 7 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-428 | KETOCONAZOLE TABLET [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_f5dc1e67-639f-5476-e053-2995a90a4210.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-428-07 | 72189042807 | 7 TABLET in 1 BOTTLE (72189-428-07) | 7 tablet | 2023-03-01 | No | No | Current |