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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

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acarbose - FDA Drug Approval Details