Clotrimazole
- Product NDC
- 68788-9665
- 11-digit product format
- 687889665
- Labeler code
- 68788
- Product ID
- 68788-9665_61f64e2c-533a-4712-8c95-fb2fbf37c054
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA072641
- Marketing category
- ANDA
- Marketing start
- 2013-08-05
- Substance
- CLOTRIMAZOLE
- Active strength
- 1 g/100g
- 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/100g |
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 |
|---|
| 68788-9665-4 | Clotrimazole | 45 g in 1 TUBE | CREAM | 45 | | 9 |
| 68788-9665-4 | Clotrimazole | 1 in 1 CARTON | CREAM | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Clotrimazole | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| Clotrimazole | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| cetyl esters wax | INACTIVE INGREDIENT | D072FFP9GU | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| octyldodecanol | INACTIVE INGREDIENT | 461N1O614Y | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9665 | CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250309_624827d6-dbf8-4f3d-a8c0-c92474cad7de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-9665-4 | 68788966504 | 1 TUBE in 1 CARTON (68788-9665-4) / 45 g in 1 TUBE | 1 tube | 2013-08-05 | 0000-00-00 | No | No | Current |