Ketoconazole
- Product NDC
- 72578-156
- 11-digit product format
- 725780156
- Labeler code
- 72578
- Product ID
- 72578-156_122ec3a2-4c9a-4f27-8c82-643b968823e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA218559
- Marketing category
- ANDA
- Marketing start
- 2025-03-08
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 106336 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72578-156-12 | Ketoconazole | 120 mL in 1 BOTTLE | SHAMPOO | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-156 | KETOCONAZOLE SHAMPOO [VIONA PHARMACEUTICALS INC] | 1 | Current NDC, 1 package rows | 20250311_a4bb3f4c-ad93-4d85-b8d0-54eaa62228fd.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 |
|---|
| 72578-156-12 | 72578015612 | 120 mL in 1 BOTTLE (72578-156-12) | 120 ml | 2025-03-08 | No | No | Historical |