Tekturna HCT

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

70839-325

Application Number

NDA022107

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 16, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AliskirenActive

Code: C8A0P8G029Class: ACTIMQuantity: 300 mg in 1 1

STARCH, WHEATInactive

Code: 79QS2MG2LPClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

Tekturna HCT

Product Details

NDC Product Code

70839-125

Application Number

NDA022107

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 16, 2022

Ingredients

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LPClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AliskirenActive

Code: C8A0P8G029Class: ACTIMQuantity: 150 mg in 1 1

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1

Tekturna HCT

Product Details

NDC Product Code

70839-112

Application Number

NDA022107

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 16, 2022

Ingredients

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AliskirenActive

Code: C8A0P8G029Class: ACTIMQuantity: 150 mg in 1 1

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LPClass: IACT

Tekturna HCT

Product Details

NDC Product Code

70839-312

Application Number

NDA022107

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 16, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

AliskirenActive

Code: C8A0P8G029Class: ACTIMQuantity: 300 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LPClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

HydrochlorothiazideActive

Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1

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Tekturna HCT

FDA Approval Summary

Products4

Tekturna HCT

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Tekturna HCT

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Tekturna HCT

Product Details

Tekturna HCT

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