Ketoconazole
- Product NDC
- 0093-3219
- 11-digit product format
- 000933219
- Labeler code
- 0093
- Product ID
- 0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- 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 | 203088 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3219 | KETOCONAZOLE CREAM [TEVA PHARMACEUTICALS USA, INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20210903_7fc47a6a-3714-4598-ae3b-d5a229262c21.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 |
|---|
| 0093-3219-15 | 00093321915 | 1 TUBE in 1 CARTON (0093-3219-15) / 15 g in 1 TUBE | 1 tube | 2019-02-08 | 0000-00-00 | No | No | Current |
| 0093-3219-30 | 00093321930 | 1 TUBE in 1 CARTON (0093-3219-30) / 30 g in 1 TUBE | 1 tube | 2019-02-08 | 0000-00-00 | No | No | Current |
| 0093-3219-92 | 00093321992 | 1 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBE | 1 tube | 2019-02-08 | 0000-00-00 | No | No | Current |