ketoconazole
- Product NDC
- 50436-4448
- 11-digit product format
- 504364448
- Labeler code
- 50436
- Product ID
- 50436-4448_9f9812a3-78f1-45ec-97b8-f1648d1bc4fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Unit Dose Services
- Application
- ANDA076294
- Marketing category
- ANDA
- Marketing start
- 2004-04-28
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record