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
4a758211-8af1-449b-9a10-f3d67d7ec8b6
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4087
Application NumberNDA021995
Product Classification
M
Marketing Category
C73594
G
Generic Name
sitagliptin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 22, 2022
FDA Product Classification
INGREDIENTS (12)
SITAGLIPTIN PHOSPHATEActive
Quantity: 25 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
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