Acarbose
Acarbose Tablets, USP
Approved
Approval ID
d1b627e1-d78d-47dd-93f5-2bf4998466ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-453
Application NumberANDA202271
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
acarbose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-455
Application NumberANDA202271
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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 Code62135-454
Application NumberANDA202271
Product Classification
M
Marketing Category
C73584
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB