Home DailyMed 13fb8c27-0a47-4cfa-a217-29cd6d14c4b8 Valsartan and Hydrochlorothiazide 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 Northwind Pharmaceuticals
Effective date 2014-05-06
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source legacy-cache
Hydrated at 2026-08-02 01:36:11 Label at a glance# Product Valsartan and Hydrochlorothiazide
Active ingredient VALSARTAN, HYDROCHLOROTHIAZIDE
Label structure 1 sections
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-951 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS] 1 Legacy NDC 20140520_13fb8c27-0a47-4cfa-a217-29cd6d14c4b8.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH 1 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 3 matching rows.
Valsartan and Hydrochlorothiazide VALSARTAN HYDROCHLOROTHIAZIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 2 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 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB 2013-03-21 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB 2013-03-21 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB 2013-03-21 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB 2013-03-21 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB 2013-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
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