Valsartan and Hydrochlorothiazide

Product NDC
71205-004
Requested package NDC
71205-004-60
11-digit product format
712050004
Labeler code
71205
Product ID
71205-004_e93bc975-109d-4ac7-9343-5213b15dd160
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091519
Marketing category
ANDA
Marketing start
2013-03-21
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
320 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71205-00471205-004-60DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-00471205-004-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-00471205-004-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-004-90EA - Each71205-0042b403cb3-56c4-42e5-bbd1-0e7e9e0b78b312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-004VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20210112_eca536fa-fdb8-4a99-a1ae-7580e2850cdb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-004-607120500046060 TABLET, FILM COATED in 1 BOTTLE (71205-004-60) 2018-04-020000-00-00NoNoCurrent