Clotrimazole
- Product NDC
- 0168-0133
- 11-digit product format
- 001680133
- Labeler code
- 0168
- Product ID
- 0168-0133_a42ebf09-c9f0-47b6-9a36-dcccda087c25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clotrimazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA078338
- Marketing category
- ANDA
- Marketing start
- 2008-09-02
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clotrimazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 309367 |
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 |
|---|
| 0168-0133-15 | Clotrimazole | 15 g in 1 TUBE | CREAM | 15 | | 7 |
| 0168-0133-30 | Clotrimazole | 30 g in 1 TUBE | CREAM | 30 | | 7 |
| 0168-0133-46 | Clotrimazole | 45 g in 1 TUBE | CREAM | 45 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| CETYL ESTERS WAX | INACTIVE INGREDIENT | D072FFP9GU | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CLOTRIMAZOLE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0133 | CLOTRIMAZOLE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20200916_28fdc2c0-fd5f-4d98-a4e1-4702a430086a.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 |
|---|
| 0168-0133-15 | 00168013315 | 15 g in 1 TUBE (0168-0133-15) | 15 g | 2008-09-02 | 0000-00-00 | No | No | Current |
| 0168-0133-30 | 00168013330 | 30 g in 1 TUBE (0168-0133-30) | 30 g | 2008-09-02 | 0000-00-00 | No | No | Current |
| 0168-0133-46 | 00168013346 | 45 g in 1 TUBE (0168-0133-46) | 45 g | 2008-09-02 | 0000-00-00 | No | No | Current |