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
NDC Product Code11788-040
Application NumberANDA213821
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2020
Generic NameACARBOSE
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
NDC Product Code11788-041
Application NumberANDA213821
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2020
Generic NameACARBOSE
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
NDC Product Code11788-039
Application NumberANDA213821
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2020
Generic NameACARBOSE
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