Acarbose
Acarbose Tablets, USP
Approved
Approval ID
352dd336-d3f9-4ac5-a000-91d3aef7aca3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-0140
Application NumberANDA078470
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0141
Application NumberANDA078470
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0142
Application NumberANDA078470
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ACARBOSEActive
Quantity: 100 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT