diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: american health packaging
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 american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-890
Product ID 60687-890_3b296539-820e-5b71-e063-6394a90ab6d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213335
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

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 60687890
Hyphenated Format 60687-890

Supplemental Identifiers

RxCUI
1190572
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 ANDA213335 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-890-01) / 1 TABLET in 1 BLISTER PACK (60687-890-11)
source: ndc

Packages (1)

60687-890-01 100 BLISTER PACK in 1 CARTON (60687-890-01) / 1 TABLET in 1 BLISTER PACK (60687-890-11)

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": "3b296539-820e-5b71-e063-6394a90ab6d9", "openfda": {"unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["d0a1c80d-6aae-4886-8c25-e2d29ca0836b"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-890-01)  / 1 TABLET in 1 BLISTER PACK (60687-890-11)", "package_ndc": "60687-890-01", "marketing_start_date": "20250801"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "60687-890_3b296539-820e-5b71-e063-6394a90ab6d9", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "60687-890", "dea_schedule": "CV", "generic_name": "diphenoxylate hydrochloride and atropine sulfate", "labeler_name": "American Health Packaging", "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": "ANDA213335", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}