| Product NDC: | 0904-0358 |
| Proprietary Name: | Hydroxyzine |
| Non Proprietary Name: | Hydroxyzine Hydrochloride |
| Active Ingredient(s): | 25 mg/1 & nbsp; Hydroxyzine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0904-0358 |
| Labeler Name: | Major Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040787 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20070320 |
| Package NDC: | 0904-0358-80 |
| Package Description: | 1000 TABLET, FILM COATED in 1 BOTTLE (0904-0358-80) |
| NDC Code | 0904-0358-80 |
| Proprietary Name | Hydroxyzine |
| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (0904-0358-80) |
| Product NDC | 0904-0358 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydroxyzine Hydrochloride |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20070320 |
| Marketing Category Name | ANDA |
| Labeler Name | Major Pharmaceuticals |
| Substance Name | HYDROXYZINE HYDROCHLORIDE |
| Strength Number | 25 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antihistamine [EPC],Histamine Receptor Antagonists [MoA] |