Miglitol
Miglitol Tablets
Approved
Approval ID
b8da2015-d254-2425-e053-2995a90acf0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2021
Manufacturers
FDA
Westminster Pharmaceuticals, LLC
DUNS: 079516651
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miglitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-303
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MIGLITOLActive
Quantity: 25 mg in 1 1
Code: 0V5436JAQW
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Miglitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-305
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MIGLITOLActive
Quantity: 100 mg in 1 1
Code: 0V5436JAQW
Classification: ACTIB
Miglitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69367-304
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIGLITOLActive
Quantity: 50 mg in 1 1
Code: 0V5436JAQW
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT