JANUVIA
These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA (sitagliptin) TabletsInitial U.S. Approval: 2006
Approved
Approval ID
963792a9-4029-4e7b-9759-9ad52e1b0962
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2013
Manufacturers
FDA
Clinical Solutions Wholesale
DUNS: 078710347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sitagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58118-0277
Application NumberNDA021995
Product Classification
M
Marketing Category
C73594
G
Generic Name
sitagliptin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2013
FDA Product Classification
INGREDIENTS (12)
SITAGLIPTIN PHOSPHATEActive
Quantity: 100 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT