Ketoconazole
- Product NDC
- 70700-160
- 11-digit product format
- 707000160
- Labeler code
- 70700
- Product ID
- 70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole Foam
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Xiromed, LLC
- Application
- ANDA213601
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/g
- 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/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 728550 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-160-19 | Ketoconazole | 50 g in 1 CAN | AEROSOL, FOAM | 50 | | 9 |
| 70700-160-20 | Ketoconazole | 100 g in 1 CAN | AEROSOL, FOAM | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-160 | KETOCONAZOLE (KETOCONAZOLE FOAM ) AEROSOL, FOAM [XIROMED, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230707_ea319889-5e58-f778-3009-5ba6a5f2690a.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 |
|---|
| 70700-160-19 | 70700016019 | 50 g in 1 CAN (70700-160-19) | 50 g | 2021-05-21 | 0000-00-00 | No | No | Current |
| 70700-160-20 | 70700016020 | 100 g in 1 CAN (70700-160-20) | 100 g | 2021-05-21 | 0000-00-00 | No | No | Current |