MedPath

ACARBOSE

Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only

Approved
Approval ID

c445953d-c20a-4b70-8173-009bffc5777b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2020

Manufacturers
FDA

Aiping Pharmaceutical

DUNS: 079674526

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 Code11788-040
Application NumberANDA213821
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2020
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: 50 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 Code11788-041
Application NumberANDA213821
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2020
FDA Product Classification

INGREDIENTS (5)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSEActive
Quantity: 100 mg in 1 1
Code: T58MSI464G
Classification: ACTIB

ACARBOSE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11788-039
Application NumberANDA213821
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACARBOSE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2020
FDA Product Classification

INGREDIENTS (5)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB

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