Package 83939-0004-1

Brand: cetirizine hydrochloride

Generic: cetirizine hydrochloride tablets
NDC Package

Package Facts

Identity

Package NDC 83939-0004-1
Digits Only 8393900041
Product NDC 83939-0004
Description

1 TABLET, FILM COATED in 1 POUCH (83939-0004-1)

Marketing

Marketing Status
Marketed Since 2025-11-10
Brand cetirizine hydrochloride
Generic cetirizine hydrochloride tablets
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "42780c27-b003-a427-e063-6394a90ace93", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["42778a1c-6894-8646-e063-6294a90a6cb5"], "manufacturer_name": ["VERITYRX, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 POUCH (83939-0004-1)", "package_ndc": "83939-0004-1", "marketing_start_date": "20251110"}, {"sample": false, "description": "50 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0004-2", "marketing_start_date": "20251103"}, {"sample": false, "description": "100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "83939-0004-3", "marketing_start_date": "20251103"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "83939-0004_42780c27-b003-a427-e063-6394a90ace93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83939-0004", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "VERITYRX, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20181217", "listing_expiration_date": "20261231"}