Package 0054-3194-46
Brand: diphenoxylate hydrochloride and atropine sulfate
Generic: diphenoxylate hydrochloride and atropine sulfatePackage 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
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"}