diphenoxylate hydrochloride and atropine sulfate
Generic: diphenoxylate hydrochloride and atropine sulfate
Labeler: winder laboratories llcDrug Facts
Product Profile
Brand Name
diphenoxylate hydrochloride and atropine sulfate
Generic Name
diphenoxylate hydrochloride and atropine sulfate
Labeler
winder laboratories llc
Dosage Form
TABLET
Routes
Active Ingredients
atropine sulfate .025 mg/1, diphenoxylate hydrochloride 2.5 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
75826-107
Product ID
75826-107_2b0ecbe9-ac10-5211-e063-6394a90a123e
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA211362
DEA Schedule
cv
Listing Expiration
2026-12-31
Marketing Start
2022-04-30
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
75826107
Hyphenated Format
75826-107
Supplemental Identifiers
RxCUI
UPC
UNII
Packaging Origin
Original Packager
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
ANDA211362 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- .025 mg/1
- 2.5 mg/1
Packaging
- 1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-00)
- 100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03)
- 10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11)
- 30 TABLET in 1 BOTTLE, PLASTIC (75826-107-33)
- 90 TABLET in 1 BOTTLE, PLASTIC (75826-107-90)
Packages (5)
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2b0ecbe9-ac10-5211-e063-6394a90a123e", "openfda": {"upc": ["0375826107036", "0375826107333", "0375826107005", "0375826107906", "0375826107111"], "unii": ["03J5ZE7KA5", "W24OD7YW48"], "rxcui": ["1190572"], "spl_set_id": ["7344a2d2-1f8a-4c5a-90e3-181b919c0c7a"], "manufacturer_name": ["Winder Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (75826-107-00)", "package_ndc": "75826-107-00", "marketing_start_date": "20220901"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (75826-107-03)", "package_ndc": "75826-107-03", "marketing_start_date": "20220901"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (75826-107-11)", "package_ndc": "75826-107-11", "marketing_start_date": "20220901"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (75826-107-33)", "package_ndc": "75826-107-33", "marketing_start_date": "20220901"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (75826-107-90)", "package_ndc": "75826-107-90", "marketing_start_date": "20220901"}], "brand_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "product_id": "75826-107_2b0ecbe9-ac10-5211-e063-6394a90a123e", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antidiarrheal [EPC]", "Cholinergic Antagonists [MoA]", "Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "75826-107", "dea_schedule": "CV", "generic_name": "Diphenoxylate Hydrochloride and Atropine Sulfate", "labeler_name": "Winder Laboratories 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": "ANDA211362", "marketing_category": "ANDA", "marketing_start_date": "20220430", "listing_expiration_date": "20261231"}