LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product NDC
35356-777
11-digit product format
353560777
Labeler code
35356
Product ID
35356-777_4803bf3d-fb5c-4eac-ab42-e188711fa441
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077912
Marketing category
ANDA
Marketing start
2006-09-27
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength
13 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-777DDiscontinued by firm2026-08-03
excluded packagepackage35356-77735356-777-30DDiscontinued by firm2026-08-03
excluded packagepackage35356-77735356-777-60DDiscontinued by firm2026-08-03
excluded packagepackage35356-77735356-777-90DDiscontinued 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 · 39 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 packagepackage35356-777-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-777-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-777-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-777-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-777-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-777-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-777-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-777-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-777-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-777-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-777-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-777-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-777-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-777-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-777-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-777-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-777-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-777-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-777-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-777-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-777-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-777-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-777-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-777-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-777-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-777-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-777-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-777-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-777-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-777-60557ba5c1ecfa…9c80585c8c6e…

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

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
A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;10MGTABLET / ORALAB2006-09-27
A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL12.5MG;20MGTABLET / ORALAB2006-09-27
A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRIL25MG;20MGTABLET / ORALAB2006-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077912-001AB
A077912-002AB
A077912-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-002LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;20MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-003LISINOPRIL AND HYDROCHLOROTHIAZIDE25MG;20MGTABLET / ORALAB2006-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077912-001LISINOPRIL AND HYDROCHLOROTHIAZIDE12.5MG;10MGTABLET / ORALAB2006-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077912-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077912-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077912-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077912-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077912-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077912-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077912-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077912-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077912-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077912-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077912-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077912-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077912-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077912-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077912-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-777-30EA - Each35356-777623ac006-06e3-4e9b-a3e1-c7a4a7d65a0b12013-02-13
35356-777-90EA - Each35356-7771172b3fc-9503-498b-bd73-74ae55c50d6112015-04-03

DailyMed Socrata Ingredients#

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.3857ac53-0435-4d68-8066-c222914148892026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.868b1442-c412-4ee8-9798-f2408cd2249a2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.408e797a-2cf3-4ee6-9f9b-179a8cf3d7992026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDECoupler LLC52b90789-2902-3ab9-e063-6394a90a5abb2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.5aa18b0b-4688-493a-a5ae-cb056ea6c0e32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack544b75eb-55f1-4164-9b83-39f6bc5fb4792026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack019ac336-0dc3-ec89-3e0a-09110e0fc30b2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackeac8c44f-cf77-6a30-cfd7-7cffffc79bd62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDESt Marys Medical Park Pharmacye7b68ea6-4fc8-441a-9640-1ccd3a482d8e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELegacy Pharmaceutical Packaging, LLC6d729ec5-7311-4534-9999-9d6fa4f3ba2f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.8808879d-8c7e-45d1-8a49-c05d2cf845d32026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.00f67e1a-6999-4295-9c9f-fcb1ce9711b82026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.ec23c75d-68d5-46d0-be56-b96ddba19ed62026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2b94985-c79d-40e3-e053-2a95a90a0d782026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCc97e38f2-7163-4d4e-a694-4d0612423e532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC3984e6b9-2d88-47f0-af09-cce428bba14f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma, Inc.c80b2164-3795-6668-e053-2a95a90a4d452025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.515f735c-5dba-43d9-8a58-97a319cafd562025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscd62e287-b648-459a-9414-621686c6b6072025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutions316e9226-e63e-466d-8143-f1edc7288fca2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077912
application number: ANDA077912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-777-303535607773030 TABLET in 1 BOTTLE (35356-777-30) 30 tablet2006-09-270000-00-00NoNoCurrent
35356-777-903535607779090 TABLET in 1 BOTTLE (35356-777-90) 90 tablet2021-06-040000-00-00NoNoCurrent