Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV
Approved
Approval ID
b0c91667-ab6f-481d-a592-62da8a52abf7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2017
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
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 Code17856-3194
Application NumberANDA087708
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2016
FDA Product Classification
INGREDIENTS (11)
ALCOHOLInactive
Quantity: 0.75 mL in 5 mL
Code: 3K9958V90M
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 5 mL
Code: 03J5ZE7KA5
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MALTOLInactive
Code: 3A9RD92BS4
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 5 mL
Code: W24OD7YW48
Classification: ACTIB