MedPath
FDA Product

JANUVIA

Product approved by U.S. Food and Drug Administration (US)

Basic Information

JANUVIA

50090-4087

Regulatory Information

50090-4087

NDA021995

C73594

July 22, 2022

USA

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

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

830016429

Active Ingredients

SITAGLIPTIN PHOSPHATE

Quantity: 25 mg in 1 1

Code: TS63EW8X6F

Class Code: ACTIM

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

talc

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

SITAGLIPTIN

Code: QFP0P1DV7Z

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