Valsartan HCTZ

Manufacturer
Northwind Pharmaceuticals
Effective date
2014-05-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:12

Label at a glance#

ProductValsartan HCTZ
Active ingredientVALSARTAN, HYDROCHLOROTHIAZIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-950-52

MFG: 0591-2316-10

Valsartan HCTZ

160/12.5MG

30 tablets

Rx only

Lot# NW23790001

Exp Date: 02/2015

Each tablet contains: 160mg of Valsartan and 12.5mg of hydrochlorothiazide, USP

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistant container (See USP)

Keep out of reach of children.

Mfg by: Arrow Pharm (Malta) Ltd. Birzebbugia, BBG06, Malta

Distr. by: Watson Pharma, Inc Parsippany, NJ 07054 USA Lot# 3019329

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

Valsartan 51655-950Valsartan 51655-950

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-950-522026-01-06C16284748780-19d75b9cf-f7dc-f424-e053-dadaa90a57ce2a29600b-500c-403e-b407-023da4381fbb
51655-950-522020-01-31C16284748780-19d75b9cf-f7dc-f424-e053-dadaa90a57ce2a29600b-500c-403e-b407-023da4381fbb

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-950VALSARTAN HCTZ TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140520_2a29600b-500c-403e-b407-023da4381fbb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2316-10EA - Each0591-23162ac710c8-a56e-4bc1-aef3-f8c63106913b12013-04-01
0591-2316-19EA - Each0591-231690f75552-3ddb-4383-a6e5-2d36b0c35ffd12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2TH1
VALSARTANACTIVE INGREDIENT80M03YXJ7I1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2TH1
VALSARTANACTIVE MOIETY80M03YXJ7I1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-95051655-950-52
0591-2316

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
VALSARTAN80M03YXJ7IACTIB
HYDROCHLOROTHIAZIDE0J48LPH2THACTIB

Source Document#

Source XML

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 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORAL2013-03-21
A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORAL2013-03-21
A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORAL2013-03-21
A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORAL2013-03-21
A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORAL2013-03-21

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-08-18 06:07:402026-07A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-2103ed91905a0d…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d92608b-f38d-40ed-e063-6294a90aa3522a29600b-500c-403e-b407-023da4381fbb2026-01-02Exact identifier
spl set id: 2a29600b-500c-403e-b407-023da4381fbb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.