| Product NDC: | 35356-043 |
| 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: | 35356-043 |
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020126 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120330 |
| Package NDC: | 35356-043-30 |
| Package Description: | 1 TUBE in 1 CARTON (35356-043-30) > 30 g in 1 TUBE |
| NDC Code | 35356-043-30 |
| Proprietary Name | Zonalon |
| Package Description | 1 TUBE in 1 CARTON (35356-043-30) > 30 g in 1 TUBE |
| Product NDC | 35356-043 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | doxepin hydrochloride |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20120330 |
| Marketing Category Name | NDA |
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Substance Name | DOXEPIN HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Tricyclic Antidepressant [EPC] |