FDA.reportPublic FDA data

Application 076265

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL12.5MG;10MGNoNo
002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL12.5MG;20MGNoNo
003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL25MG;20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORAL2002-07-08
A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORAL2002-07-08
A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORAL2002-07-08

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0884e616aacf4f…
2026-09-14 22:38:342026-08A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0884e616aacf4f…
2026-09-14 22:38:342026-08A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0884e616aacf4f…
2026-08-18 06:07:402026-07A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08caaa826d4ba7…
2026-08-18 06:07:402026-07A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08caaa826d4ba7…
2026-08-18 06:07:402026-07A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076265-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORAL2002-07-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076265-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORAL2002-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076265-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORAL2002-07-08301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076265-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076265-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076265-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076265-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076265-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076265-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076265-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076265-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076265-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076265-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076265-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076265-003AB1ea99ee380514…

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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedd7214539-6c3d-466a-a474-6fde096fa1822026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSt. Mary's Medical Park Pharmacye1aa9682-b1ad-4a22-e053-2a95a90a0e2f2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.3857ac53-0435-4d68-8066-c222914148892026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.868b1442-c412-4ee8-9798-f2408cd2249a2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.408e797a-2cf3-4ee6-9f9b-179a8cf3d7992026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSSt. Mary's Medical Park Pharmacy00b266d9-ac4a-e931-e063-6294a90a6a0b2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDECoupler LLC52b90789-2902-3ab9-e063-6394a90a5abb2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.5956a107-0f7b-49e7-b9c9-36790349b06e2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.5aa18b0b-4688-493a-a5ae-cb056ea6c0e32026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.9207c3bc-e12e-4017-8b85-0f928e744f642026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSPreferred Pharmaceuticals Inc.fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack544b75eb-55f1-4164-9b83-39f6bc5fb4792026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack019ac336-0dc3-ec89-3e0a-09110e0fc30b2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackeac8c44f-cf77-6a30-cfd7-7cffffc79bd62026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDESt Marys Medical Park Pharmacye7b68ea6-4fc8-441a-9640-1ccd3a482d8e2026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELegacy Pharmaceutical Packaging, LLC6d729ec5-7311-4534-9999-9d6fa4f3ba2f2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions7d4ee5ec-5b68-453b-8d6e-214457a581592026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSA-S Medication Solutions62e8c093-cd8e-4342-aadb-209c7e6699c82026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lisinopril and Hydrochlorothiazide

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
43353-800Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-975Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2086Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
52959-997Lisinopril with HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEH.J. Harkins Company, Inc.ANDACurrent
66267-751Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-751Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-752Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-752Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
67544-276Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-6364Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7389Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0081Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-0284Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0284Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideBryant Ranch PrepackANDACurrent