Miglitol
Miglitol Tablets
Approved
Approval ID
f16ecb50-e54e-43e1-8789-eaf5bc94f332
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-937
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
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 Code71205-936
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MIGLITOLActive
Quantity: 50 mg in 1 1
Code: 0V5436JAQW
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Miglitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-935
Application NumberANDA203965
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglitol
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2022
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MIGLITOLActive
Quantity: 25 mg in 1 1
Code: 0V5436JAQW
Classification: ACTIB