Tekturna HCT

These highlights do not include all the information needed to use TEKTURNA HCT safely and effectively. See full prescribing information for TEKTURNA HCT. TEKTURNA HCT (aliskiren and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2008

Approved

Approval ID

8df0ca6a-58cf-41fc-b890-5c7fa5a3792c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2022

Manufacturers

FDA

Noden Pharma USA, Inc.

DUNS: 932134773

Products 4

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

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70839-325

Application NumberNDA022107

Product Classification

Marketing Category

C73594

Generic Name

aliskiren hemifumarate and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 16, 2022

FDA Product Classification

INGREDIENTS (14)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALISKIREN HEMIFUMARATEActive

Quantity: 300 mg in 1 1

Code: C8A0P8G029

Classification: ACTIM

STARCH, WHEATInactive

Code: 79QS2MG2LP

Classification: IACT

HYDROCHLOROTHIAZIDEActive

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70839-125

Application NumberNDA022107

Product Classification

Marketing Category

C73594

Generic Name

aliskiren hemifumarate and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 16, 2022

FDA Product Classification

INGREDIENTS (14)

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LP

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALISKIREN HEMIFUMARATEActive

Quantity: 150 mg in 1 1

Code: C8A0P8G029

Classification: ACTIM

HYDROCHLOROTHIAZIDEActive

Quantity: 25 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70839-112

Application NumberNDA022107

Product Classification

Marketing Category

C73594

Generic Name

aliskiren hemifumarate and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 16, 2022

FDA Product Classification

INGREDIENTS (14)

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALISKIREN HEMIFUMARATEActive

Quantity: 150 mg in 1 1

Code: C8A0P8G029

Classification: ACTIM

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LP

Classification: IACT

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70839-312

Application NumberNDA022107

Product Classification

Marketing Category

C73594

Generic Name

aliskiren hemifumarate and hydrochlorothiazide

Product Specifications

Route of AdministrationORAL

Effective DateNovember 16, 2022

FDA Product Classification

INGREDIENTS (14)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

ALISKIREN HEMIFUMARATEActive

Quantity: 300 mg in 1 1

Code: C8A0P8G029

Classification: ACTIM

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, WHEATInactive

Code: 79QS2MG2LP

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

HYDROCHLOROTHIAZIDEActive

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Classification: ACTIB

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Tekturna HCT

Products 4

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

aliskiren hemifumarate and hydrochlorothiazide

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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