Jentadueto
These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. Jentadueto (linagliptin and metformin hydrochloride) tabletsInitial U.S. Approval: 2012
Approved
Approval ID
9822b5fa-6024-445a-a36d-a26106c69845
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2015
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.
linagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6461
Application NumberNDA201281
Product Classification
M
Marketing Category
C73594
G
Generic Name
linagliptin
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2015
FDA Product Classification
INGREDIENTS (12)
metformin hydrochlorideActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
linagliptinActive
Quantity: 2.5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
copovidoneInactive
Code: D9C330MD8B
Classification: IACT
arginineInactive
Code: 94ZLA3W45F
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT