ACARBOSE
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only
Approved
Approval ID
6cd185e6-3205-484c-be49-456acfc7eb11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2019
Manufacturers
FDA
Virtus Pharmaceuticals LLC
DUNS: 079659493
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 Code69543-121
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2018
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69543-122
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2018
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 100 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69543-120
Application NumberANDA091343
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2018
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT