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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

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Motofen - FDA Drug Approval Details