Clotrimazole
- Product NDC
- 51672-2158
- 11-digit product format
- 516722158
- Labeler code
- 51672
- Product ID
- 51672-2158_38e57cf6-01a5-2089-e063-6294a90ad0e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-23
- Substance
- CLOTRIMAZOLE
- Active strength
- 1 g/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 51672-2158_38e57cf6-01a5-2089-e063-6294a90ad0e6
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Clotrimazole
- Generic name
- Clotrimazole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Marketing start
- 2024-09-23
- Marketing category
- OTC MONOGRAPH DRUG
- Application number
- M005
- Pharmacologic classes
- Azole Antifungal [EPC]; Azoles [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 1 g/mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Spl Set Id | 13a14d3c-bfce-42b5-8463-4ec69e94774e |
| Manufacturer Name | Sun Pharmaceutical Industries, Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G07GZ97H65 | CLOTRIMAZOLE | 23593-75-1 | CLOTRIMAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-2158-1 | 51672215801 | 1 BOTTLE in 1 CARTON (51672-2158-1) / 10 mL in 1 BOTTLE | 1 bottle | 2024-09-23 | No | No | Current |