Package 0054-3194-46

Brand: diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate
NDC Package

Package Facts

Identity

Package NDC 0054-3194-46
Digits Only 0054319446
Product NDC 0054-3194
Description

1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 1982-05-03
Brand diphenoxylate hydrochloride and atropine sulfate
Generic diphenoxylate hydrochloride and atropine sulfate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "92ce86bc-7f23-43ec-9374-a51bacef9461", "openfda": {"unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190568"], "spl_set_id": ["88ed4ccf-9e35-4142-a5eb-d2b5edd36956"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-3194-46)  / 60 mL in 1 BOTTLE", "package_ndc": "0054-3194-46", "marketing_start_date": "19820503"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0054-3194", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenoxylate Hydrochloride and Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".025 mg/5mL"}, {"name": "DIPHENOXYLATE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "ANDA087708", "marketing_category": "ANDA", "marketing_start_date": "19820503", "listing_expiration_date": "20261231"}