| Product NDC: | 10337-804 |
| Proprietary Name: | Zonalon |
| Non Proprietary Name: | doxepin hydrochloride |
| Active Ingredient(s): | 50 mg/g & nbsp; doxepin hydrochloride |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 10337-804 |
| Labeler Name: | PharmaDerm A division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020126 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19940401 |
| Package NDC: | 10337-804-45 |
| Package Description: | 1 TUBE in 1 CARTON (10337-804-45) > 45 g in 1 TUBE |
| NDC Code | 10337-804-45 |
| Proprietary Name | Zonalon |
| Package Description | 1 TUBE in 1 CARTON (10337-804-45) > 45 g in 1 TUBE |
| Product NDC | 10337-804 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | doxepin hydrochloride |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 19940401 |
| Marketing Category Name | NDA |
| Labeler Name | PharmaDerm A division of Fougera Pharmaceuticals Inc. |
| Substance Name | DOXEPIN HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Tricyclic Antidepressant [EPC] |