Package 83745-185-08

Brand: cetirizine hydrochloride oral solution

Generic: cetirizine hydrochloride oral solution
NDC Package

Package Facts

Identity

Package NDC 83745-185-08
Digits Only 8374518508
Product NDC 83745-185
Description

240 mL in 1 BOTTLE (83745-185-08)

Marketing

Marketing Status
Marketed Since 2024-12-20
Brand cetirizine hydrochloride oral solution
Generic cetirizine hydrochloride oral solution
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b350aaa9-197e-4ebc-8315-6ea307dcdb2e", "openfda": {"upc": ["0383745185042", "0383745185165", "0383745185080"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9c6a440b-bd0f-414b-bab3-3b2f57c479d7"], "manufacturer_name": ["APOZEAL PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (83745-185-04)", "package_ndc": "83745-185-04", "marketing_start_date": "20241220"}, {"sample": false, "description": "240 mL in 1 BOTTLE (83745-185-08)", "package_ndc": "83745-185-08", "marketing_start_date": "20241220"}, {"sample": false, "description": "480 mL in 1 BOTTLE (83745-185-16)", "package_ndc": "83745-185-16", "marketing_start_date": "20241220"}], "brand_name": "Cetirizine Hydrochloride Oral Solution", "product_id": "83745-185_b350aaa9-197e-4ebc-8315-6ea307dcdb2e", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83745-185", "generic_name": "Cetirizine Hydrochloride Oral Solution", "labeler_name": "APOZEAL PHARMACEUTICALS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride Oral Solution", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078870", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20271231"}