acarbose
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only
Approved
Approval ID
858c8cdd-ccf1-79c9-c245-7a852d280f20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-132
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ACARBOSEActive
Quantity: 100 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-131
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-130
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB