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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

eb81a45f-05b8-49de-99ce-5089bd360d9b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 16, 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 Code50090-4086
Application NumberNDA021995
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 22, 2022
Generic Namesitagliptin

INGREDIENTS (12)

SITAGLIPTIN PHOSPHATEActive
Quantity: 50 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
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JANUVIA - FDA Approval | MedPath