Ketoconazole
- Product NDC
- 70771-1874
- 11-digit product format
- 707711874
- Labeler code
- 70771
- Product ID
- 70771-1874_9795147c-bca9-481c-b910-edee5bdd5f29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 70771-1874-7 | Ketoconazole | 120 mL in 1 BOTTLE | SHAMPOO | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1874 | KETOCONAZOLE SHAMPOO [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, 1 package rows | 20250315_c004ee91-558a-450b-9e4e-d11ab9d28054.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 |
|---|
| 70771-1874-7 | 70771187407 | 120 mL in 1 BOTTLE (70771-1874-7) | 120 ml | 2025-03-08 | No | No | Historical |