Valsartan and Hydrochlorothiazide

Product NDC
50090-2640
11-digit product format
500902640
Labeler code
50090
Product ID
50090-2640_035f0c0c-f4f9-4483-9e60-9a0598d33c2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2640IInactivated by FDA2026-10-05
excluded packagepackage50090-264050090-2640-0IInactivated by FDA2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2640-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2640-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2640-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2640-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2640-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2640-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2640-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2640-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2640-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2640-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2640-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2640-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2640-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2640-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2640-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-2640-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-2640-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-2640-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-2640-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-2640-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-2640-09bebd1f3094a…5416666fcb17…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2640-0Valsartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2640-0EA - Each50090-2640c4124377-30c2-446e-a796-74ed76f7749212019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2640VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Legacy NDC, 1 package rows20190225_6a33116d-1ee8-4761-8a21-ad80ac26f9df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN6a33116d-1ee8-4761-8a21-ad80ac26f9df8
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD6a33116d-1ee8-4761-8a21-ad80ac26f9df8
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSY6a33116d-1ee8-4761-8a21-ad80ac26f9df8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2640-05009026400090 in 1 BOTTLEHistorical