Nizoral
- Product NDC
- 55505-232
- 11-digit product format
- 555050232
- Labeler code
- 55505
- Product ID
- 55505-232_adf1b4c5-24ad-4b4e-8ad6-f28d77d244ea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Kramer Laboratories
- Application
- NDA020310
- Marketing category
- NDA
- Marketing start
- 2025-10-01
- Substance
- KETOCONAZOLE
- Active strength
- 1 g/100mL
- 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
- Nizoral
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 1 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 240812, 608844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55505-232-65 | Nizoral | 400 mL in 1 CARTON | SHAMPOO | 400 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55505-232-65 | 55505023265 | 400 mL in 1 CARTON (55505-232-65) | 400 ml | 2025-10-01 | No | No | Current |