ketoconazole
- Product NDC
- 71335-2943
- 11-digit product format
- 713352943
- Labeler code
- 71335
- Product ID
- 71335-2943_77c68629-b9d4-45d7-bffb-5d3cbfdbb7fb
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ketoconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 2 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 728550 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2943-1 | ketoconazole | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 100 |
| 71335-2943-1 | ketoconazole | 100 g in 1 CANISTER | AEROSOL, FOAM | 100 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2943-1 | 71335294301 | 1 CANISTER in 1 CARTON (71335-2943-1) / 100 g in 1 CANISTER | 1 canister | 2025-10-24 | No | No | Current |