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FDA Drug information

Valsartan and hydrochlorothiazide

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221105

Version

4

Spl Product Data Elements

valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE PINK OVAL 279 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000 brownish red OVAL 280 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000 BROWN oval 282 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE pink oval 281 valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide VALSARTAN VALSARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 4000 TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE BROWN OVAL 283

Application Number

ANDA203000

Brand Name

Valsartan and hydrochlorothiazide

Generic Name

valsartan and hydrochlorothiazide

Product Ndc

70771-1485

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg NDC 70771-1485-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg NDC 70771-1486-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg NDC 70771-1487-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg NDC 70771-1488-0 in bottle of 1000 tablets 1000 tablets Rx only Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg NDC 70771-1489-0 in bottle of 1000 tablets 1000 tablets Rx only 80 mg/ 12.5 mg 160 mg/ 12.5 mg 160 mg/ 25 mg 320 mg/ 12.5 mg 320 mg/ 25 mg

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