SEGLUROMET
These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
Approved
Approval ID
a6aeb99a-ce49-4125-90ce-642df3f1ebad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ertugliflozin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5373
Application NumberNDA209806
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (12)
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 2.5 mg in 1 1
Code: MLU731K321
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ertugliflozin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5370
Application NumberNDA209806
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (12)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 7.5 mg in 1 1
Code: MLU731K321
Classification: ACTIM
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ertugliflozin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5374
Application NumberNDA209806
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (12)
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 7.5 mg in 1 1
Code: MLU731K321
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ertugliflozin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5369
Application NumberNDA209806
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (12)
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 2.5 mg in 1 1
Code: MLU731K321
Classification: ACTIM
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT