Valsartan and Hydrochlorothiazide

Product NDC
0781-5952
11-digit product format
007815952
Labeler code
0781
Product ID
0781-5952_ff7a21b8-e6b1-4111-a48f-143877db39eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020818
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-21
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
E
Listing certified through
2018-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5952DDiscontinued by firm2026-08-03
excluded packagepackage0781-59520781-5952-10DDiscontinued by firm2026-08-03
excluded packagepackage0781-59520781-5952-37DDiscontinued by firm2026-08-03
excluded packagepackage0781-59520781-5952-64DDiscontinued by firm2026-08-03
excluded packagepackage0781-59520781-5952-92DDiscontinued by firm2026-08-03

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5952-64DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5952-92DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5952-37DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5952-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5952-92IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5952-10IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5952-64IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5952-37IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5952-92IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5952-10IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5952-64IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5952-37IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5952-92IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5952-10IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5952-64IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5952-37IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5952-92IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5952-10IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5952-64IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5952-37IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5952-92IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5952-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5952-64IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5952-37IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5952-92IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5952-10IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5952-64IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5952-37IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5952-92IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5952-10IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5952-64IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5952-37IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5952-92IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5952-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5952-64IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5952-37IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5952-92IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5952-10IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5952-64IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5952-37IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5952-92IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5952-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5952-64IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5952-37IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5952-92IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5952-10IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5952-64IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5952-37IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020818-001DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALABRLD1998-03-06
N020818-002DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALABRLD1998-03-06
N020818-003DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALABRLD2002-01-17
N020818-004DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALABRLD2006-04-28
N020818-005DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALABRLD, RS2006-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
N020818-001AB
N020818-002AB
N020818-003AB
N020818-004AB
N020818-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005AB15bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0781-5952-102025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-372025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-642025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-922025-11-20These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-102020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-372020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-642020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998
0781-5952-922020-01-31These highlights do not include all the information needed to use Valsartan and Hydrochlorothiazide Tablets, USP safely and effectively. See full prescribing information for Valsartan and Hydrochlorothiazide Tablets, USP. Valsartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1998

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5952-10EA - Each0781-5952ee36ef0e-6939-4dd9-9746-f7d6edbf838212013-02-13
0781-5952-64EA - Each0781-59527f34aa47-7981-45da-8835-8170cd0a5d8212013-02-13
0781-5952-92EA - Each0781-59524cf2f2ad-3327-40bc-b86e-5dcef1772bbe12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5952VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4Legacy NDC20141016_f1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e.zip

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
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020818
application number: NDA020818