ketoconazole
- Product NDC
- 63629-8676
- 11-digit product format
- 636298676
- Labeler code
- 63629
- Product ID
- 63629-8676_8443f3a1-8b03-4f97-9759-e1b925b3ae37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091550
- Marketing category
- ANDA
- Marketing start
- 2011-08-30
- Substance
- KETOCONAZOLE
- Active strength
- 2 g/100g
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R9400W927I | KETOCONAZOLE | 65277-42-1 | KETOCONAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-8676-1 | 63629867601 | 1 CANISTER in 1 CARTON (63629-8676-1) / 50 g in 1 CANISTER | 1 canister | 2011-08-30 | No | No | Historical |