diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: leading pharma, llc
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 leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-910
Product ID 69315-910_af054a1c-a0a1-4097-8170-3e7b070ad830
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213413
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2020-03-15

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 69315910
Hyphenated Format 69315-910

Supplemental Identifiers

RxCUI
1190572
UPC
0369315910092 0369315910016 0369315910108
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 ANDA213413 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69315-910-01)
  • 90 TABLET in 1 BOTTLE (69315-910-09)
  • 1000 TABLET in 1 BOTTLE (69315-910-10)
source: ndc

Packages (3)

69315-910-01 100 TABLET in 1 BOTTLE (69315-910-01) 69315-910-09 90 TABLET in 1 BOTTLE (69315-910-09) 69315-910-10 1000 TABLET in 1 BOTTLE (69315-910-10)

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": "af054a1c-a0a1-4097-8170-3e7b070ad830", "openfda": {"upc": ["0369315910092", "0369315910016", "0369315910108"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["1c188bc9-7c21-4717-94a0-cdfb581fb776"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-910-01)", "package_ndc": "69315-910-01", "marketing_start_date": "20200315"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69315-910-09)", "package_ndc": "69315-910-09", "marketing_start_date": "20200315"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69315-910-10)", "package_ndc": "69315-910-10", "marketing_start_date": "20200315"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "69315-910_af054a1c-a0a1-4097-8170-3e7b070ad830", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "69315-910", "dea_schedule": "CV", "generic_name": "diphenoxylate hydrochloride and atropine sulfate", "labeler_name": "Leading Pharma, 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": "ANDA213413", "marketing_category": "ANDA", "marketing_start_date": "20200315", "listing_expiration_date": "20261231"}