KETOCONAZOLE
- Product NDC
- 70518-2831
- 11-digit product format
- 705182831
- Labeler code
- 70518
- Product ID
- 70518-2831_d76e8782-d61b-669b-e053-2995a90a9b67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075912
- Marketing category
- ANDA
- Marketing start
- 2020-08-10
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 200 mg/1
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2831-0 | 70518283100 | 30 TABLET in 1 BLISTER PACK (70518-2831-0) | 30 tablet | 2020-08-10 | 0000-00-00 | No | No | Current |
| 70518-2831-1 | 70518283101 | 7 TABLET in 1 BOTTLE, PLASTIC (70518-2831-1) | 7 tablet | 2020-09-08 | 0000-00-00 | No | No | Current |