NDC Code | 11534-204-03 |
Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03) |
Product NDC | 11534-204 |
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 | 20240416 |
Marketing Category Name | ANDA |
Application Number | ANDA207121 |
Manufacturer | Sunrise Pharmaceutical, Inc. |
Substance Name | HYDROXYZINE DIHYDROCHLORIDE |
Strength | 10 |
Strength Unit | mg/1 |
Pharmacy Classes | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |