Package 0378-3637-05
Brand: cetirizine hydrochloride
Generic: cetirizine hydrochloridePackage Facts
Identity
Package NDC
0378-3637-05
Digits Only
0378363705
Product NDC
0378-3637
Description
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05)
Marketing
Marketing Status
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": "5670c6c3-a4ab-4268-917a-99e0579f3079", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["487ae0f0-320c-4534-b9e2-0e215f167cea"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01)", "package_ndc": "0378-3637-01", "marketing_start_date": "20071227"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05)", "package_ndc": "0378-3637-05", "marketing_start_date": "20071227"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "0378-3637_5670c6c3-a4ab-4268-917a-99e0579f3079", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0378-3637", "generic_name": "cetirizine hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076677", "marketing_category": "ANDA", "marketing_start_date": "20071227", "listing_expiration_date": "20261231"}