STEGLUJAN
These highlights do not include all the information needed to use STEGLUJAN safely and effectively. See full prescribing information for STEGLUJAN. STEGLUJAN (ertugliflozin and sitagliptin) tablets, for oral use Initial U.S. Approval: 2017
Approved
Approval ID
c2c553d8-5a9d-4366-bf53-8bdb5a876d19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ertugliflozin and sitagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5367
Application NumberNDA209805
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and sitagliptin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (15)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 5 mg in 1 1
Code: MLU731K321
Classification: ACTIM
SITAGLIPTIN PHOSPHATEActive
Quantity: 100 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ertugliflozin and sitagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5368
Application NumberNDA209805
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and sitagliptin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (15)
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 15 mg in 1 1
Code: MLU731K321
Classification: ACTIM
SITAGLIPTIN PHOSPHATEActive
Quantity: 100 mg in 1 1
Code: TS63EW8X6F
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT