Ketoconazole
- Product NDC
- 68788-7755
- 11-digit product format
- 687887755
- Labeler code
- 68788
- Product ID
- 68788-7755_e5366532-915c-4f04-a7bd-646fd2055725
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7755 | KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20240530_074bcd7b-a9cc-44bd-a78a-0d150c04cc1e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7755-1 | 68788775501 | 1 TUBE in 1 CARTON (68788-7755-1) > 15 g in 1 TUBE | 1 tube | 2020-07-01 | 0000-00-00 | No | No | Current |
| 68788-7755-3 | 68788775503 | 1 TUBE in 1 CARTON (68788-7755-3) > 30 g in 1 TUBE | 1 tube | 2020-07-01 | 0000-00-00 | No | No | Current |