Package 80513-731-05

Brand: cetirizine hydrochloride

Generic: cetirizine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 80513-731-05
Digits Only 8051373105
Product NDC 80513-731
Description

500 TABLET, COATED in 1 BOTTLE (80513-731-05)

Marketing

Marketing Status
Marketed Since 2025-05-01
Brand cetirizine hydrochloride
Generic cetirizine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "35019a5a-fbea-124b-e063-6394a90a5ec4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["737492bf-96bd-4f7c-aa42-4910746f44bb"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (80513-731-05)", "package_ndc": "80513-731-05", "marketing_start_date": "20250501"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (80513-731-12)", "package_ndc": "80513-731-12", "marketing_start_date": "20250501"}], "brand_name": "Cetirizine hydrochloride", "product_id": "80513-731_35019a5a-fbea-124b-e063-6394a90a5ec4", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "80513-731", "generic_name": "Cetirizine hydrochloride", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}