Acarbose
Acarbose Tablets
Approved
Approval ID
656769ee-e292-4950-83df-a38e6b1a9d6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2022
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-760
Application NumberANDA090912
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2022
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSEActive
Quantity: 100 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-758
Application NumberANDA090912
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2022
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-759
Application NumberANDA090912
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2022
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT