motofen

Generic: difenoxin and atropine sulfate

Labeler: sebela pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name motofen
Generic Name difenoxin and atropine sulfate
Labeler sebela pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

atropine sulfate .025 mg/1, difenoxin hydrochloride 1 mg/1

Manufacturer
Sebela Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 54766-200
Product ID 54766-200_43144b43-adf2-3d58-e063-6394a90a2b81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017744
DEA Schedule civ
Marketing Start 2017-04-11
Marketing End 2028-08-31

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 54766200
Hyphenated Format 54766-200

Supplemental Identifiers

RxCUI
1190738 1190740
UPC
0354766200106
UNII
03J5ZE7KA5 VQZ63K01IW

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 motofen (source: ndc)
Generic Name difenoxin and atropine sulfate (source: ndc)
Application Number NDA017744 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (54766-200-10)
source: ndc

Packages (1)

54766-200-10 100 TABLET in 1 BOTTLE (54766-200-10)

Ingredients (2)

atropine sulfate (.025 mg/1) difenoxin hydrochloride (1 mg/1)

Linked Drug Pages (1)

Motofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43144b43-adf2-3d58-e063-6394a90a2b81", "openfda": {"upc": ["0354766200106"], "unii": ["03J5ZE7KA5", "VQZ63K01IW"], "rxcui": ["1190738", "1190740"], "spl_set_id": ["4cd3f029-a5e3-5812-e054-00144ff8d46c"], "manufacturer_name": ["Sebela Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (54766-200-10)", "package_ndc": "54766-200-10", "marketing_end_date": "20280831", "marketing_start_date": "20170411"}], "brand_name": "Motofen", "product_id": "54766-200_43144b43-adf2-3d58-e063-6394a90a2b81", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "54766-200", "dea_schedule": "CIV", "generic_name": "difenoxin and atropine sulfate", "labeler_name": "Sebela Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Motofen", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".025 mg/1"}, {"name": "DIFENOXIN HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "NDA017744", "marketing_category": "NDA", "marketing_end_date": "20280831", "marketing_start_date": "20170411"}