lomotil

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lomotil
Generic Name diphenoxylate hydrochloride and atropine sulfate
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0025-0061
Product ID 0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA012462
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 1960-09-15

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 00250061
Hyphenated Format 0025-0061

Supplemental Identifiers

RxCUI
1190572 1190641
UPC
0300250061319
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 lomotil (source: ndc)
Generic Name diphenoxylate hydrochloride and atropine sulfate (source: ndc)
Application Number NDA012462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0025-0061-31)
source: ndc

Packages (1)

0025-0061-31 100 TABLET in 1 BOTTLE (0025-0061-31)

Ingredients (2)

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

Linked Drug Pages (1)

Lomotil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "69fba82d-8e83-4efb-8c88-5175fda71617", "openfda": {"upc": ["0300250061319"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572", "1190641"], "spl_set_id": ["f170584a-1072-4fd7-b1dc-6756703483b9"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0025-0061-31)", "package_ndc": "0025-0061-31", "marketing_start_date": "19600915"}], "brand_name": "Lomotil", "product_id": "0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0025-0061", "dea_schedule": "CV", "generic_name": "diphenoxylate hydrochloride and atropine sulfate", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lomotil", "active_ingredients": [{"name": "ATROPINE SULFATE", "strength": ".025 mg/1"}, {"name": "DIPHENOXYLATE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "NDA012462", "marketing_category": "NDA", "marketing_start_date": "19600915", "listing_expiration_date": "20271231"}