Motofen
Motofen® (difenoxin and atropine sulfate tablets) CIV Rx Only
Approved
Approval ID
4cd3f029-a5e3-5812-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2018
Manufacturers
FDA
Sebela Pharmaceuticals Inc.
DUNS: 079104574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
difenoxin and atropine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54766-200
Application NumberNDA017744
Product Classification
M
Marketing Category
C73594
G
Generic Name
difenoxin and atropine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2018
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
DIFENOXIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: VQZ63K01IW
Classification: ACTIM
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT