diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diphenoxylate hydrochloride and atropine sulfate
Generic Name diphenoxylate hydrochloride and atropine sulfate
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atropine sulfate .025 mg/1, diphenoxylate hydrochloride 2.5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 76385-107
Product ID 76385-107_606720c6-e55e-4338-b18a-1e1b5018ab7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210819
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

Pharmacologic Class

Classes
anticholinergic [epc] antidiarrheal [epc] cholinergic antagonists [moa] cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76385107
Hyphenated Format 76385-107

Supplemental Identifiers

RxCUI
1190572
UPC
0376385107017
UNII
03J5ZE7KA5 W24OD7YW48

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenoxylate hydrochloride and atropine sulfate (source: ndc)
Generic Name diphenoxylate hydrochloride and atropine sulfate (source: ndc)
Application Number ANDA210819 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76385-107-01)
  • 1000 TABLET in 1 BOTTLE (76385-107-10)
source: ndc

Packages (2)

76385-107-01 100 TABLET in 1 BOTTLE (76385-107-01) 76385-107-10 1000 TABLET in 1 BOTTLE (76385-107-10)

Ingredients (2)

atropine sulfate (.025 mg/1) diphenoxylate hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

Diphenoxylate Hydrochloride and Atropine Sulfate ndc-match (0.9)

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"}