Valsartan and Hydrochlorothiazide

Product NDC
70518-0576
11-digit product format
705180576
Labeler code
70518
Product ID
70518-0576_860e0f7b-8128-f332-e053-2991aa0af11e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202519
Marketing category
ANDA
Marketing start
2017-06-14
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
2020-12-31
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 productproduct70518-0576DDiscontinued by firm2026-08-03
excluded packagepackage70518-057670518-0576-0DDiscontinued 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 1 · 24 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 packagepackage70518-0576-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0576-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0576-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0576-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0576-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0576-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0576-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0576-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0576-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-0576-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-0576-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-0576-0557ba5c1ecfa…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
A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2013-03-21
A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2013-03-21
A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2013-03-21
A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2013-03-21
A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2013-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202519-001AB
A202519-002AB
A202519-003AB
A202519-004AB
A202519-005AB

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 UTC2026-02A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-004VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-215bbf6a4d5a75…

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 UTC2026-02A202519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202519-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202519-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202519-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202519-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202519-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202519-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202519-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202519-005AB15bbf6a4d5a75…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedc5bc7c55-b50c-4e61-ad1f-5ebb607c262f2024-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202519
application number: ANDA202519
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP75b3f944-b4fc-40a5-a4e2-aec2fbab64b82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202519
application number: ANDA202519
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP411caa05-5eff-4285-a940-7f6d2429ba812019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202519
application number: ANDA202519
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPe1f94546-c71c-4175-9384-20238181e05f2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202519
application number: ANDA202519
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LP1f6ab5e0-8320-4489-bed2-8c90c534e5ae2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202519
application number: ANDA202519