Ketoconazole
- Product NDC
- 70518-2027
- 11-digit product format
- 705182027
- Labeler code
- 70518
- Product ID
- 70518-2027_86b14f9f-1561-2234-e053-2a91aa0a17a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075597
- Marketing category
- ANDA
- Marketing start
- 2019-04-16
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record