1% ketoconazole
- Product NDC
- 85384-0001
- 11-digit product format
- 853840001
- Labeler code
- 85384
- Product ID
- 85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- TAGRID LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-31
- Substance
- KETOCONAZOLE
- Active strength
- 10 mg/mL
- 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
- 1% ketoconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85384-0001-1 | 1% ketoconazole | 250 mL in 1 BOTTLE | SHAMPOO | 250 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85384-0001 | 1% KETOCONAZOLE (KETOCONAZOLE) SHAMPOO [TAGRID LLC] | 1 | Current NDC, 1 package rows | 20250331_30b75584-3a1e-c125-e063-6294a90acaa7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85384-0001-1 | 85384000101 | 250 mL in 1 BOTTLE (85384-0001-1) | 250 ml | 2025-03-31 | No | No | Current |