diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: redpharm drug 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 redpharm drug inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Redpharm Drug Inc.

Identifiers & Regulatory

Product NDC 67296-1485
Product ID 67296-1485_2c62c754-969a-47f7-e063-6294a90a94fe
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 672961485
Hyphenated Format 67296-1485

Supplemental Identifiers

RxCUI
1190572
UPC
0369315910108 0369315910016 0369315910092
UNII
03J5ZE7KA5 W24OD7YW48

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 (67296-1485-9)
source: ndc

Packages (1)

67296-1485-9 100 TABLET in 1 BOTTLE (67296-1485-9)

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": "2c62c754-969a-47f7-e063-6294a90a94fe", "openfda": {"upc": ["0369315910108", "0369315910016", "0369315910092"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["f4c35a82-5927-5bc2-e053-2a95a90aea4d"], "manufacturer_name": ["Redpharm Drug Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67296-1485-9)", "package_ndc": "67296-1485-9", "marketing_start_date": "20200315"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "67296-1485_2c62c754-969a-47f7-e063-6294a90a94fe", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "67296-1485", "dea_schedule": "CV", "generic_name": "diphenoxylate hydrochloride and atropine sulfate", "labeler_name": "Redpharm Drug 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": "ANDA213413", "marketing_category": "ANDA", "marketing_start_date": "20200315", "listing_expiration_date": "20261231"}