Package 11534-204-03

Brand: hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 11534-204-03
Digits Only 1153420403
Product NDC 11534-204
Description

1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)

Marketing

Marketing Status
Marketed Since 2024-04-16
Brand hydroxyzine hydrochloride
Generic hydroxyzine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4f0e9eea-4f47-49fe-a609-790dada173d0", "openfda": {"upc": ["0311534204032", "0311534206036"], "unii": ["76755771U3"], "rxcui": ["995218", "995258", "995281"], "spl_set_id": ["94561525-a565-4193-b64d-e1459ab05678"], "manufacturer_name": ["Sunrise Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01)", "package_ndc": "11534-204-01", "marketing_start_date": "20240416"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03)", "package_ndc": "11534-204-03", "marketing_start_date": "20240416"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04)", "package_ndc": "11534-204-04", "marketing_start_date": "20250110"}], "brand_name": "HYDROXYZINE HYDROCHLORIDE", "product_id": "11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "11534-204", "generic_name": "hydroxyzine hydrochloride", "labeler_name": "Sunrise Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207121", "marketing_category": "ANDA", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}