Lisinopril with Hydrochlorothiazide

Product NDC
67544-276
11-digit product format
675440276
Labeler code
67544
Product ID
67544-276_8630b890-129e-4ef3-b8cb-afc47305a71e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076265
Marketing category
ANDA
Marketing start
2002-07-08
Marketing end
0000-00-00
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
20 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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-276DDiscontinued by firm2026-10-05
excluded packagepackage67544-27667544-276-60DDiscontinued by firm2026-10-05
excluded packagepackage67544-27667544-276-80DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage67544-276-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-276-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-276-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-276-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-276-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-276-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-276-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-276-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-276-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-276-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-276-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-276-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-276-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67544-276-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-276-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67544-276-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-276-800efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67544-276-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67544-276-80ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67544-276-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67544-276-80367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67544-276-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67544-276-80557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67544-276-60557ba5c1ecfa…9c80585c8c6e…

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…

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
67544-276-60EA - Each67544-27629472220-ab98-4ae1-bcbd-3e0d9d5c7e3512013-07-02
67544-276-80EA - Each67544-276c1eedd66-a8f2-41ea-982d-fa2e9cfea7d312014-07-02