Package 83745-188-12
Brand: cetrizine hydrochloride
Generic: cetirizine hydrochloridePackage Facts
Identity
Package NDC
83745-188-12
Digits Only
8374518812
Product NDC
83745-188
Description
120 mL in 1 BOTTLE, PLASTIC (83745-188-12)
Marketing
Marketing Status
Brand
cetrizine 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": "4af0cd5e-46c5-4571-9e04-b8bf16f21b50", "openfda": {"upc": ["0383745188241"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9c0549cf-4c93-45d9-9eac-3948fa45554e"], "manufacturer_name": ["APOZEAL PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE", "package_ndc": "83745-188-04", "marketing_start_date": "20260120"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE", "package_ndc": "83745-188-08", "marketing_start_date": "20260120"}, {"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (83745-188-12)", "package_ndc": "83745-188-12", "marketing_start_date": "20260120"}, {"sample": false, "description": "240 mL in 1 BOTTLE, PLASTIC (83745-188-24)", "package_ndc": "83745-188-24", "marketing_start_date": "20260120"}], "brand_name": "Cetrizine Hydrochloride", "product_id": "83745-188_4af0cd5e-46c5-4571-9e04-b8bf16f21b50", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83745-188", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "APOZEAL PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetrizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA090474", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20271231"}