Valsartan And Hydrochlorothiazide Tablets

SPL v4

SPL

SPL Set ID bd199010-1d85-4011-939c-4704ecfaba1f

Route

ORAL

Published

Effective Date 2019-10-23

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Valsartan (80 mg) Hydrochlorothiazide (12.5 mg)

Inactive Ingredients

Anhydrous Dibasic Calcium Phosphate Cellulose, Microcrystalline Crospovidone Ferric Oxide Red Ferric Oxide Yellow Hypromelloses Magnesium Stearate Polyethylene Glycol 4000 Silicon Dioxide Talc Titanium Dioxide Ferrosoferric Oxide

Identifiers & Packaging

Pill Appearance

Imprint: 283 Shape: oval Color: pink Color: brown Size: 12 mm Size: 17 mm Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2020-02-12

Description

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

Medication Information

Description

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

Structured Label Content

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

Advanced Ingredient Data

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"unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 4000", "unii": "4R4HFI6D95", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": 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Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:24.797622 · Updated: 2026-03-14T21:49:59.697322