Acarbose
Acarbose Tablets
Approved
Approval ID
26bca6c9-074d-480d-bd57-1e8fa9b3d05e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-5945
Application NumberANDA078470
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2010
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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT