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Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

64764-254

Application Number

NDA022426

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 4, 2023

Ingredients

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

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Product Details

NDC Product Code

64764-253

Application Number

NDA022426

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 4, 2023

Ingredients

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

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Product Details

NDC Product Code

64764-251

Application Number

NDA022426

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 4, 2023

Ingredients

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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Product Details

NDC Product Code

64764-123

Application Number

NDA022426

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

December 4, 2023

Ingredients

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 12.5 mg in 1 1

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYGLYCERYL-10 OLEATEInactive

Code: 55C81W76DHClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

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