Clotrimazole
- Product NDC
- 68788-8491
- 11-digit product format
- 687888491
- Labeler code
- 68788
- Product ID
- 68788-8491_ebbd70fb-8dd2-4bc8-b814-1e346558565a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA074165
- Marketing category
- ANDA
- Marketing start
- 2023-07-24
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/g
- 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 | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 309368 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8491-4 | Clotrimazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | | 4 |
| 68788-8491-4 | Clotrimazole | 1 in 1 CARTON | CREAM | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8491 | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250309_fd010006-f646-46ed-841a-9f247b19e397.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8491-4 | 68788849104 | 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4) / 45 g in 1 TUBE, WITH APPLICATOR | 2023-07-24 | No | No | Historical |