Clotrimazole
- Product NDC
- 21695-935
- 11-digit product format
- 216950935
- Labeler code
- 21695
- Product ID
- 21695-935_3cd19aeb-0555-44cd-9619-a2490c8c21e1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA074165
- Marketing category
- ANDA
- Marketing start
- 1993-07-16
- Marketing end
- 0000-00-00
- Substance
- CLOTRIMAZOLE
- Active strength
- 50 mg/g
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-935-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4b87-48b1-e053-8cdaa90a720a | Clotrimazole Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-935-45 | Clotrimazole | 45 g in 1 TUBE | CREAM | 45 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-935-45 | GM - Gram | 21695-935 | e8115343-0269-452b-8979-fa4b57fdd278 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| CETYL ESTERS WAX | INACTIVE INGREDIENT | D072FFP9GU | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| OCTYLDODECYL STEARATE | INACTIVE INGREDIENT | K6F16QGO28 | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-935-45 | 21695093545 | 45 g in 1 TUBE | 45 g | Historical |