KETOCONAZOLE
- Product NDC
- 72789-052
- 11-digit product format
- 727890052
- Labeler code
- 72789
- Product ID
- 72789-052_40311e8f-76f8-b6b1-e063-6394a90aa4c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOCONAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA210457
- Marketing category
- ANDA
- Marketing start
- 2018-06-26
- 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 |
|---|
| 72789-052-30 | KETOCONAZOLE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-052 | KETOCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241010_f162e616-21b4-49b1-b437-15e21001a6f0.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 |
|---|
| 72789-052-30 | 72789005230 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-052-30) | 30 tablet | 2022-12-08 | 0000-00-00 | No | No | Current |