Alogliptin and Pioglitazone

Products6

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

Product Details

NDC Product Code

45802-499

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

MannitolInactive

Code: 3OWL53L36AClass: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

Hypromellose 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Polyethylene Glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

Ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Ferric oxide RedInactive

Code: 1K09F3G675Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Alogliptin and Pioglitazone

Product Details

NDC Product Code

45802-238

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 12.5 mg in 1 1

MannitolInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Hypromellose 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

Polyethylene Glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

Ferric oxide RedInactive

Code: 1K09F3G675Class: IACT

Carnauba waxInactive

Code: R12CBM0EIZClass: IACT

Polyglyceryl-10 oleateInactive

Code: 55C81W76DHClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Alogliptin and Pioglitazone

Product Details

NDC Product Code

45802-402

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1

MannitolInactive

Code: 3OWL53L36AClass: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: 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

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

Ferric oxide RedInactive

Code: 1K09F3G675Class: IACT

Ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Alogliptin and Pioglitazone

Product Details

NDC Product Code

45802-304

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

MannitolInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 12.5 mg in 1 1

Carnauba waxInactive

Code: R12CBM0EIZClass: IACT

Polyglyceryl-10 oleateInactive

Code: 55C81W76DHClass: IACT

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 45 mg in 1 1

Hypromellose 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Polyethylene Glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Ferric oxide RedInactive

Code: 1K09F3G675Class: IACT

Alogliptin and Pioglitazone

Product Details

NDC Product Code

45802-260

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 30 mg in 1 1

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 12.5 mg in 1 1

MannitolInactive

Code: 3OWL53L36AClass: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Hypromellose 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Polyethylene Glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

Ferric oxide RedInactive

Code: 1K09F3G675Class: IACT

Carnauba waxInactive

Code: R12CBM0EIZClass: IACT

Polyglyceryl-10 oleateInactive

Code: 55C81W76DHClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

Alogliptin and Pioglitazone

Product Details

NDC Product Code

45802-351

Application Number

NDA022426

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 31, 2022

Ingredients

PioglitazoneActive

Code: JQT35NPK6CClass: ACTIMQuantity: 15 mg in 1 1

AlogliptinActive

Code: EEN99869SCClass: ACTIMQuantity: 25 mg in 1 1

MannitolInactive

Code: 3OWL53L36AClass: IACT

Microcrystalline CelluloseInactive

Code: OP1R32D61UClass: IACT

Croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

Hypromellose 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

AlcoholInactive

Code: 3K9958V90MClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

Polyethylene Glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

TalcInactive

Code: 7SEV7J4R1UClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Ferric oxide yellowInactive

Code: EX438O2MRTClass: IACT

Ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

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Alogliptin and Pioglitazone

FDA Approval Summary

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