diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: hikma 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 hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

atropine sulfate .025 mg/5mL, diphenoxylate hydrochloride 2.5 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3194
Product ID 0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087708
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 1982-05-03

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 00543194
Hyphenated Format 0054-3194

Supplemental Identifiers

RxCUI
1190568
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 ANDA087708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

0054-3194-46 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE

Ingredients (2)

atropine sulfate (.025 mg/5mL) diphenoxylate hydrochloride (2.5 mg/5mL)

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": "92ce86bc-7f23-43ec-9374-a51bacef9461", "openfda": {"unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190568"], "spl_set_id": ["88ed4ccf-9e35-4142-a5eb-d2b5edd36956"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0054-3194-46)  / 60 mL in 1 BOTTLE", "package_ndc": "0054-3194-46", "marketing_start_date": "19820503"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0054-3194", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diphenoxylate Hydrochloride and Atropine Sulfate", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".025 mg/5mL"}, {"name": "DIPHENOXYLATE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "ANDA087708", "marketing_category": "ANDA", "marketing_start_date": "19820503", "listing_expiration_date": "20261231"}