diphenoxylate hydrochloride and atropine sulfate (68071-4063)

Drug Facts

Product Profile

Brand Name diphenoxylate hydrochloride and atropine sulfate

Generic Name diphenoxylate hydrochloride and atropine sulfate

Labeler nucare pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4063

Product ID 68071-4063_1d8dd9e3-f2b7-7894-e063-6394a90a29d3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA086727

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2017-06-20

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 680714063

Hyphenated Format 68071-4063

Supplemental Identifiers

RxCUI

1190572

UPC

0368071406313

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 ANDA086727 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.025 mg/1
2.5 mg/1

source: ndc

Packaging

10 TABLET in 1 BOTTLE (68071-4063-1)
20 TABLET in 1 BOTTLE (68071-4063-2)
30 TABLET in 1 BOTTLE (68071-4063-3)
15 TABLET in 1 BOTTLE (68071-4063-5)

source: ndc

Packages (4)

68071-4063-1 10 TABLET in 1 BOTTLE (68071-4063-1) 68071-4063-2 20 TABLET in 1 BOTTLE (68071-4063-2) 68071-4063-3 30 TABLET in 1 BOTTLE (68071-4063-3) 68071-4063-5 15 TABLET in 1 BOTTLE (68071-4063-5)

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": "1d8dd9e3-f2b7-7894-e063-6394a90a29d3", "openfda": {"upc": ["0368071406313"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["575c38b4-7ec0-6d25-e053-2a91aa0a80fc"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-4063-1)", "package_ndc": "68071-4063-1", "marketing_start_date": "20170822"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-4063-2)", "package_ndc": "68071-4063-2", "marketing_start_date": "20170822"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-4063-3)", "package_ndc": "68071-4063-3", "marketing_start_date": "20170822"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68071-4063-5)", "package_ndc": "68071-4063-5", "marketing_start_date": "20170822"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "68071-4063_1d8dd9e3-f2b7-7894-e063-6394a90a29d3", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68071-4063", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "NuCare Pharmaceuticals,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": "ANDA086727", "marketing_category": "ANDA", "marketing_start_date": "20170620", "listing_expiration_date": "20261231"}