Precose
PRECOSE ( acarbose tablets)
Approved
Approval ID
e2158832-ad0b-4b9c-bbf0-1608a177bf85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2012
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 Code54868-5831
Application NumberNDA020482
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acarbose
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2012
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 25 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT