Package 43353-083-53

Brand: diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate
NDC Package

Package Facts

Identity

Package NDC 43353-083-53
Digits Only 4335308353
Product NDC 43353-083
Description

60 TABLET in 1 BOTTLE (43353-083-53)

Marketing

Marketing Status
Marketed Since 2015-07-14
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": "a923a016-80b4-4a98-9494-ada455890843", "openfda": {"unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["59934cee-4e1f-4958-9e97-6de53b39daf3"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-083-30)", "package_ndc": "43353-083-30", "marketing_start_date": "20150713"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-083-53)", "package_ndc": "43353-083-53", "marketing_start_date": "20150714"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-083-60)", "package_ndc": "43353-083-60", "marketing_start_date": "20150713"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (43353-083-70)", "package_ndc": "43353-083-70", "marketing_start_date": "20150713"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-083-80)", "package_ndc": "43353-083-80", "marketing_start_date": "20150815"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (43353-083-90)", "package_ndc": "43353-083-90", "marketing_start_date": "20150727"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "43353-083_a923a016-80b4-4a98-9494-ada455890843", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43353-083", "dea_schedule": "CV", "generic_name": "DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenoxylate Hydrochloride and Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".025 mg/1"}, {"name": "DIPHENOXYLATE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "NDA012462", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130227", "listing_expiration_date": "20261231"}