JANUVIA
These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA (sitagliptin) tablets, for oral useInitial U.S. Approval: 2006
Approved
Approval ID
194c3718-5eb5-4cf5-85d0-2bb1ed8293b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sitagliptin
PRODUCT DETAILS
NDC Product Code50090-3472
Application NumberNDA021995
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 1, 2023
Generic Namesitagliptin
INGREDIENTS (13)
SITAGLIPTIN PHOSPHATEActive
Quantity: 50 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT