NDC 10337-163
Temovate
Clobetasol Propionate
Temovate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc.. The primary component is Clobetasol Propionate.
| Product ID | 10337-163_17dbbb71-8c20-449c-aa10-67b7d40aee18 |
| NDC | 10337-163 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Temovate |
| Generic Name | Clobetasol Propionate |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 1996-09-30 |
| Marketing End Date | 2022-06-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA074392 |
| Labeler Name | PharmaDerm a division of Fougera Pharmaceuticals Inc. |
| Substance Name | CLOBETASOL PROPIONATE |
| Active Ingredient Strength | 1 mg/g |
| Pharm Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| NDC Exclude Flag | N |
Packaging
NDC 10337-163-30
1 TUBE in 1 CARTON (10337-163-30) > 30 g in 1 TUBE
| Marketing Start Date | 1996-09-30 |
| Marketing End Date | 2022-06-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 10337-163-30 [10337016330]
Temovate CREAM
| Marketing Category | ANDA |
| Application Number | ANDA074392 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1996-09-30 |
NDC 10337-163-60 [10337016360]
Temovate CREAM
| Marketing Category | ANDA |
| Application Number | ANDA074392 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 1996-09-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
OpenFDA Data
| SPL SET ID: | acecf5ab-dd5e-4046-ab47-b9ff415d4b2b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
- Corticosteroid [EPC]
- Corticosteroid Hormone Receptor Agonists [MoA]
NDC Crossover Matching brand name "Temovate" or generic name "Clobetasol Propionate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0462-0269 | Temovate | Clobetasol Propionate |
| 0462-0293 | Temovate | clobetasol propionate |
| 10337-163 | Temovate | Temovate |
| 10337-162 | Temovate | Temovate |
| 0168-0162 | Clobetasol Propionate | clobetasol propionate |
| 0168-0163 | Clobetasol Propionate | clobetasol propionate |
| 0168-0269 | Clobetasol Propionate | Clobetasol Propionate |
| 0168-0293 | Clobetasol Propionate | clobetasol propionate |
| 0378-8055 | Clobetasol Propionate | Clobetasol Propionate |
| 0378-8167 | clobetasol propionate | clobetasol propionate |
| 0378-8190 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0400 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0402 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0403 | Clobetasol Propionate | Clobetasol Propionate |
| 0472-0404 | Clobetasol Propionate | Clobetasol Propionate |
| 0574-2063 | Clobetasol Propionate | CLOBETASOL PROPIONATE |
| 0574-2103 | Clobetasol Propionate | Clobetasol Propionate |
| 0168-0301 | Clobetasol Propionate (emollient) | clobetasol propionate |
| 0299-3847 | Clobex | clobetasol propionate |
| 0299-3848 | Clobex | Clobetasol Propionate |
| 0299-3849 | CLOBEX | clobetasol propionate |
| 0378-8182 | OLUX | clobetasol propionate |
| 0378-8147 | OLUX-E | clobetasol propionate |
Trademark Results [Temovate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMOVATE 73585431 1428974 Live/Registered |
GLAXO GROUP LIMITED 1986-03-03 |
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