Ketoconazole
- Product NDC
- 70518-0762
- 11-digit product format
- 705180762
- Labeler code
- 70518
- Product ID
- 70518-0762_d88bd5a0-ae9d-0d81-e053-2a95a90acf7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2017-10-06
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0762-0 | 70518076200 | 1 TUBE in 1 CARTON (70518-0762-0) > 15 g in 1 TUBE | 1 tube | 2017-10-06 | 0000-00-00 | No | No | Current |