FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
50090-6153
11-digit product format
500906153
Labeler code
50090
Product ID
50090-6153_14ef6563-75f5-4cc0-917e-6ad835f3c561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203145
Marketing category
ANDA
Marketing start
2013-04-19
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
13 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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-6153DDiscontinued by firm2026-10-02
excluded packagepackage50090-615350090-6153-0DDiscontinued by firm2026-10-02
excluded packagepackage50090-615350090-6153-1DDiscontinued by firm2026-10-02

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 · 6 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 packagepackage50090-6153-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-6153-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-6153-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-6153-0f5e01cc5f278…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
A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2013-04-19
A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2013-04-19
A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2013-04-19
A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2013-04-19
A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2013-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203145-001AB
A203145-002AB
A203145-003AB
A203145-004AB
A203145-005AB

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-09-14 22:38:342026-08A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1984e616aacf4f…
2026-08-18 06:07:402026-07A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-04-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203145-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203145-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A203145-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203145-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203145-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203145-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203145-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203145-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203145-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203145-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203145-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203145-005AB103ed91905a0d…

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
50090-6153-0EA - Each50090-61532a32384f-9d6c-489b-90d9-bfc85aa7604812022-12-07
50090-6153-1EA - Each50090-615399cd5539-3b3a-4a03-ad2c-f9cdacc0c3f612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6153VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC20231102_2ac6b8fa-4045-4126-a4b8-37d09a785a5a.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC191d5710-7b8a-0b61-e063-6394a90afd412026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb118092-2002-7a55-e053-2a95a90a7b2c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb4d84ce-cf51-61dc-e053-2a95a90a2cfd2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1f2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack497223a9-0d53-4f79-b031-07cc5204d80f2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions89ce2fb1-330c-45f9-bd37-b402feea93782023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsef100fa1-dd63-4287-8543-480a82ace1682023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited771afba6-8769-4ea8-afec-358dba0aaefe2022-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPa9098fc6-3d2a-404f-a4cd-2e181ebbd6262022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe0349fe8-90a4-4236-9686-f0c9c00a001c2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203145
application number: ANDA203145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6153-05009061530090 TABLET, FILM COATED in 1 BOTTLE (50090-6153-0) 2022-10-060000-00-00NoNoCurrent
50090-6153-15009061530130 TABLET, FILM COATED in 1 BOTTLE (50090-6153-1) 2022-10-060000-00-00NoNoCurrent