Clotrimazole
- Product NDC
- 71399-0500
- 11-digit product format
- 713990500
- Labeler code
- 71399
- Product ID
- 71399-0500_5113af13-6054-1881-e063-6394a90aa5fc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Akron Pharma Inc
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-13
- Substance
- CLOTRIMAZOLE
- Active strength
- 1 g/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clotrimazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 1 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71399-0500-1 | Clotrimazole | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 7 |
| 71399-0500-3 | Clotrimazole | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71399-0500 | CLOTRIMAZOLE SOLUTION [AKRON PHARMA INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240919_692d7e0f-50d4-4abb-8c74-36bc98064fe7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71399-0500-1 | 71399050001 | 10 mL in 1 BOTTLE (71399-0500-1) | 10 ml | 2024-09-13 | 0000-00-00 | No | No | Current |
| 71399-0500-3 | 71399050003 | 30 mL in 1 BOTTLE (71399-0500-3) | 30 ml | 2024-09-13 | | No | No | Historical |