Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Valsartan and Hydrochlorothiazide

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 110342024

Effective Date

March 7, 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Valsartan(80 mg in 1 1)

Hydrochlorothiazide(12.5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Novartis Pharmaceuticals Corporation

DUNS Number

002147023

Products5

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

Valsartan and Hydrochlorothiazide

Product Details

NDC Product Code

0781-5948

Application Number

NDA020818

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 7, 2014

Ingredients

ValsartanActive

Code: 80M03YXJ7IClass: ACTIBQuantity: 80 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HydrochlorothiazideActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

Valsartan and Hydrochlorothiazide

Product Details

NDC Product Code

0781-5949

Application Number

NDA020818

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 7, 2014

Ingredients

ValsartanActive

Code: 80M03YXJ7IClass: ACTIBQuantity: 160 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HydrochlorothiazideActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Valsartan and Hydrochlorothiazide

Product Details

NDC Product Code

0781-5951

Application Number

NDA020818

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 7, 2014

Ingredients

HydrochlorothiazideActive

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

ValsartanActive

Code: 80M03YXJ7IClass: ACTIBQuantity: 320 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Valsartan and Hydrochlorothiazide

Product Details

NDC Product Code

0781-5952

Application Number

NDA020818

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 7, 2014

Ingredients

ValsartanActive

Code: 80M03YXJ7IClass: ACTIBQuantity: 320 mg in 1 1

HydrochlorothiazideActive

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

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Valsartan and Hydrochlorothiazide

Product Details

NDC Product Code

0781-5950

Application Number

NDA020818

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

March 7, 2014

Ingredients

HydrochlorothiazideActive

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

ValsartanActive

Code: 80M03YXJ7IClass: ACTIBQuantity: 160 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy