Home DailyMed bd199010-1d85-4011-939c-4704ecfaba1f VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2022-11-05
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 4
Source full-release
Hydrated at 2026-05-31 20:44:51 Label at a glance# Product valsartan and hydrochlorothiazide
Active ingredient VALSARTAN, HYDROCHLOROTHIAZIDE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 200284 HCTZ 12.5 MG / valsartan 80 MG Oral Tablet PSN 4 200285 valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet PSN 4 349353 valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet PSN 4 636042 valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet PSN 4 636045 valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet PSN 4 200285 hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet SCD 4 636042 hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet SCD 4 200284 hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet SCD 4 349353 hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet SCD 4 636045 hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet SCD 4 200285 HCTZ 12.5 MG / valsartan 160 MG Oral Tablet SY 4 636042 HCTZ 12.5 MG / valsartan 320 MG Oral Tablet SY 4 200284 HCTZ 12.5 MG / valsartan 80 MG Oral Tablet SY 4 349353 HCTZ 25 MG / valsartan 160 MG Oral Tablet SY 4 636045 HCTZ 25 MG / valsartan 320 MG Oral Tablet SY 4
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1485-0 valsartan and hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 70771-1485-4 valsartan and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 4 70771-1485-4 valsartan and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 70771-1485-9 valsartan and hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 4 70771-1486-0 valsartan and hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 70771-1486-4 valsartan and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 4 70771-1486-4 valsartan and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 70771-1486-9 valsartan and hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 4 70771-1487-0 valsartan and hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 70771-1487-4 valsartan and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 70771-1487-4 valsartan and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 4 70771-1487-9 valsartan and hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 4 70771-1488-0 valsartan and hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 70771-1488-4 valsartan and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 4 70771-1488-4 valsartan and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 70771-1488-9 valsartan and hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 4 70771-1489-0 valsartan and hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 70771-1489-4 valsartan and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 4 70771-1489-4 valsartan and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 70771-1489-9 valsartan and hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1485 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip 70771-1486 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip 70771-1487 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip 70771-1488 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip 70771-1489 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221109_bd199010-1d85-4011-939c-4704ecfaba1f.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 15 matching rows.
valsartan and hydrochlorothiazide VALSARTAN 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 FERROSOFERRIC OXIDE NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 70771-1485 70771-1485-9 , 70771-1485-0 , 70771-1485-4 70771-1486 70771-1486-9 , 70771-1486-0 , 70771-1486-4 70771-1487 70771-1487-9 , 70771-1487-0 , 70771-1487-4 70771-1488 70771-1488-9 , 70771-1488-0 , 70771-1488-4 70771-1489 70771-1489-9 , 70771-1489-0 , 70771-1489-4
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 2 · 68 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL 2019-03-15 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL 2019-03-15 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL 2019-03-15 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL 2019-03-15 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL 2019-03-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 220 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 b8a1b40f171c…
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