diphenoxylate hydrochloride and atropine sulfate

Generic: diphenoxylate hydrochloride and atropine sulfate

Labeler: aphena pharma solutions - tennessee, llc
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 aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-594
Product ID 43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17
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 43353594
Hyphenated Format 43353-594

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 ANDA086727 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .025 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43353-594-30)
  • 60 TABLET in 1 BOTTLE (43353-594-53)
  • 90 TABLET in 1 BOTTLE (43353-594-60)
  • 120 TABLET in 1 BOTTLE (43353-594-70)
  • 180 TABLET in 1 BOTTLE (43353-594-80)
  • 240 TABLET in 1 BOTTLE (43353-594-90)
source: ndc

Packages (6)

43353-594-30 30 TABLET in 1 BOTTLE (43353-594-30) 43353-594-53 60 TABLET in 1 BOTTLE (43353-594-53) 43353-594-60 90 TABLET in 1 BOTTLE (43353-594-60) 43353-594-70 120 TABLET in 1 BOTTLE (43353-594-70) 43353-594-80 180 TABLET in 1 BOTTLE (43353-594-80) 43353-594-90 240 TABLET in 1 BOTTLE (43353-594-90)

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": "ef69e563-7239-4c78-8fb4-3cd641fbff17", "openfda": {"unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["435e5e75-5a4c-4806-8d9e-d4be3fef9229"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-594-30)", "package_ndc": "43353-594-30", "marketing_start_date": "20170726"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-594-53)", "package_ndc": "43353-594-53", "marketing_start_date": "20170726"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-594-60)", "package_ndc": "43353-594-60", "marketing_start_date": "20170726"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (43353-594-70)", "package_ndc": "43353-594-70", "marketing_start_date": "20170726"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-594-80)", "package_ndc": "43353-594-80", "marketing_start_date": "20170726"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (43353-594-90)", "package_ndc": "43353-594-90", "marketing_start_date": "20170726"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43353-594", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}