Package 0121-0874-16
Brand: cetirizine hydrochloride
Generic: cetirizine hydrochloridePackage Facts
Identity
Package NDC
0121-0874-16
Digits Only
0121087416
Product NDC
0121-0874
Description
480 mL in 1 BOTTLE (0121-0874-16)
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": "31dc1106-c6ed-4dcd-81e3-206cbd47017b", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["71448ab0-e23e-4cf7-940e-7d67e7362fb4"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (0121-0874-04)", "package_ndc": "0121-0874-04", "marketing_start_date": "20240621"}, {"sample": false, "description": "480 mL in 1 BOTTLE (0121-0874-16)", "package_ndc": "0121-0874-16", "marketing_start_date": "20240212"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0121-0874", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078412", "marketing_category": "ANDA", "marketing_start_date": "20240212", "listing_expiration_date": "20261231"}