Package 68788-8435-3
Brand: cetirizine hydrochloride
Generic: cetirizine hydrochloride tabletsPackage Facts
Identity
Package NDC
68788-8435-3
Digits Only
6878884353
Product NDC
68788-8435
Description
30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3)
Marketing
Marketing Status
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": "f859a35b-2461-42aa-bbc9-7a75ec8c2881", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["14a885e5-5e75-4a18-b5bc-6aaa748712db"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3)", "package_ndc": "68788-8435-3", "marketing_start_date": "20230427"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6)", "package_ndc": "68788-8435-6", "marketing_start_date": "20230427"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9)", "package_ndc": "68788-8435-9", "marketing_start_date": "20230427"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "68788-8435_f859a35b-2461-42aa-bbc9-7a75ec8c2881", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8435", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230427", "listing_expiration_date": "20261231"}