Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
Approved
Approval ID
dce0127b-2712-41db-aa74-325e3d215998
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-1934
Application NumberANDA086727
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2017
FDA Product Classification
INGREDIENTS (7)
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB