Ketoconazole
- Product NDC
- 16714-955
- 11-digit product format
- 167140955
- Labeler code
- 16714
- Product ID
- 16714-955_494f72d9-37d0-5066-e063-6394a90a95bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketoconazole
- Listing expiration
- 2027-12-31
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 |
|---|
| 16714-955 | KETOCONAZOLE CREAM [NORTHSTAR RX LLC] | 1 | Current NDC, Legacy NDC, 6 package rows | 20190516_bf3e48fd-e063-42e6-acd1-580ddc6e93be.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 |
|---|
| 16714-955-01 | 16714095501 | 1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBE | 1 tube | 2019-04-25 | 0000-00-00 | No | No | Current |
| 16714-955-02 | 16714095502 | 1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBE | 1 tube | 2019-04-25 | 0000-00-00 | No | No | Current |
| 16714-955-03 | 16714095503 | 1 TUBE in 1 CARTON (16714-955-03) / 60 g in 1 TUBE | 1 tube | 2019-04-25 | 0000-00-00 | No | No | Current |