Package 76385-107-10

Brand: diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate
NDC Package

Package Facts

Identity

Package NDC 76385-107-10
Digits Only 7638510710
Product NDC 76385-107
Description

1000 TABLET in 1 BOTTLE (76385-107-10)

Marketing

Marketing Status
Marketed Since 2019-05-15
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": "606720c6-e55e-4338-b18a-1e1b5018ab7d", "openfda": {"upc": ["0376385107017"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["5117f26c-488f-4ba6-b115-22baf12557f3"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76385-107-01)", "package_ndc": "76385-107-01", "marketing_start_date": "20190515"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76385-107-10)", "package_ndc": "76385-107-10", "marketing_start_date": "20190515"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "76385-107_606720c6-e55e-4338-b18a-1e1b5018ab7d", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "76385-107", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "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": "ANDA210819", "marketing_category": "ANDA", "marketing_start_date": "20190515", "listing_expiration_date": "20261231"}