Ketoconazole
- Product NDC
- 71205-105
- 11-digit product format
- 712050105
- Labeler code
- 71205
- Product ID
- 71205-105_c7f1508c-9478-4379-9c50-4d5a6b8cdcef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO, SUSPENSION
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076942
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- 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 |
|---|
| 71205-105-72 | Ketoconazole | 120 mL in 1 BOTTLE, PLASTIC | SHAMPOO, SUSPENSION | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-105 | KETOCONAZOLE SHAMPOO, SUSPENSION [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 1 package rows | 20221111_cb1908da-443d-40b8-b8c7-b115bc2d37e0.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 |
|---|
| 71205-105-72 | 71205010572 | 120 mL in 1 BOTTLE, PLASTIC (71205-105-72) | 120 ml | 2018-09-04 | 0000-00-00 | No | No | Current |