SEGLUROMET

Products (4)

NDC Product Code

0006-5373

Application Number

NDA209806

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 12, 2023

Ingredients

Ertugliflozin pidolateActive

Code: MLU731K321Class: ACTIMQuantity: 2.5 mg in 1 1

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

SEGLUROMET

NDC Product Code

0006-5370

Application Number

NDA209806

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 12, 2023

Ingredients

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

Ertugliflozin pidolateActive

Code: MLU731K321Class: ACTIMQuantity: 7.5 mg in 1 1

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

SEGLUROMET

NDC Product Code

0006-5374

Application Number

NDA209806

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 12, 2023

Ingredients

Ertugliflozin pidolateActive

Code: MLU731K321Class: ACTIMQuantity: 7.5 mg in 1 1

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SEGLUROMET

NDC Product Code

0006-5369

Application Number

NDA209806

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 12, 2023

Ingredients

Ertugliflozin pidolateActive

Code: MLU731K321Class: ACTIMQuantity: 2.5 mg in 1 1

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

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SEGLUROMET

Products (4)

SEGLUROMET

SEGLUROMET

SEGLUROMET

SEGLUROMET