NDC Code | 80425-0394-2 |
Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0394-2) |
Product NDC | 80425-0394 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydroxyzine Hydrochloride |
Non-Proprietary Name | Hydroxyzine Hydrochloride |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20240524 |
Marketing Category Name | ANDA |
Application Number | ANDA217652 |
Manufacturer | Advanced Rx of Tennessee, LLC |
Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
Strength | 50 |
Strength Unit | mg/1 |
Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |