| Product NDC: | 0603-1310 |
| Proprietary Name: | Hydroxyzine Hydrochloride |
| Non Proprietary Name: | hydroxyzine hydrochloride |
| Active Ingredient(s): | 10 mg/5mL & nbsp; hydroxyzine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0603-1310 |
| Labeler Name: | Qualitest Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040391 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20020410 |
| Package NDC: | 0603-1310-54 |
| Package Description: | 120 mL in 1 BOTTLE (0603-1310-54) |
| NDC Code | 0603-1310-54 |
| Proprietary Name | Hydroxyzine Hydrochloride |
| Package Description | 120 mL in 1 BOTTLE (0603-1310-54) |
| Product NDC | 0603-1310 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydroxyzine hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20020410 |
| Marketing Category Name | ANDA |
| Labeler Name | Qualitest Pharmaceuticals |
| Substance Name | HYDROXYZINE HYDROCHLORIDE |
| Strength Number | 10 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Antihistamine [EPC],Histamine Receptor Antagonists [MoA] |