Package 84441-713-10
Brand: loperamide hydrochloride and simethicone
Generic: loperamide hydrochloride and simethiconePackage Facts
Identity
Package NDC
84441-713-10
Digits Only
8444171310
Product NDC
84441-713
Description
100 TABLET in 1 BOTTLE (84441-713-10)
Marketing
Marketing Status
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": "41d6dba5-e412-c8d2-e063-6294a90ae8fa", "openfda": {"nui": ["N0000010282"], "upc": ["0860010278123"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["41d6dba5-e411-c8d2-e063-6294a90ae8fa"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["IMO-GEN LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (84441-713-10)", "package_ndc": "84441-713-10", "marketing_start_date": "20251023"}], "brand_name": "Loperamide Hydrochloride and Simethicone", "product_id": "84441-713_41d6dba5-e412-c8d2-e063-6294a90ae8fa", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "84441-713", "generic_name": "Loperamide Hydrochloride and Simethicone", "labeler_name": "IMO-GEN LABS LLC", "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": "ANDA211438", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}