Acarbose
Acarbose
Approved
Approval ID
6fb339f5-a3c5-4069-bd39-fc2c28e677ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-951
Application NumberNDA020482
Product Classification
M
Marketing Category
C73605
G
Generic Name
acarbose
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2014
FDA Product Classification
INGREDIENTS (5)
ACARBOSEActive
Quantity: 50 mg in 1 1
Code: T58MSI464G
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT