Package 53041-263-50
Brand: loperamide hydrochloride, simethicone
Generic: loperamide hydrochloride, simethiconePackage Facts
Identity
Package NDC
53041-263-50
Digits Only
5304126350
Product NDC
53041-263
Description
1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK
Marketing
Marketing Status
Brand
loperamide hydrochloride, simethicone
Generic
loperamide hydrochloride, simethicone
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "289e6064-8eb8-4b56-bc9e-ee82ad83674f", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["1b79204e-8a99-455b-84d6-f381fd7d1135"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK", "package_ndc": "53041-263-50", "marketing_start_date": "20210601"}], "brand_name": "Loperamide Hydrochloride, Simethicone", "product_id": "53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "53041-263", "generic_name": "Loperamide Hydrochloride, Simethicone", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride, Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA214541", "marketing_category": "ANDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}