Package 69452-531-12

Brand: loperamide hydrochloride and simethicone

Generic: loperamide hydrochloride and simethicone
NDC Package

Package Facts

Identity

Package NDC 69452-531-12
Digits Only 6945253112
Product NDC 69452-531
Description

4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2026-01-07
Brand loperamide hydrochloride and simethicone
Generic loperamide hydrochloride and simethicone
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47a779be-990b-5c3b-e063-6394a90ac456", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["47a779c7-c709-6208-e063-6394a90a6dfa"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (69452-531-12)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "69452-531-12", "marketing_start_date": "20260107"}], "brand_name": "Loperamide hydrochloride and Simethicone", "product_id": "69452-531_47a779be-990b-5c3b-e063-6394a90ac456", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "69452-531", "generic_name": "loperamide hydrochloride and simethicone", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide hydrochloride and Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA213484", "marketing_category": "ANDA", "marketing_start_date": "20260107", "listing_expiration_date": "20271231"}