Lisinopril

Product NDC
68788-9821
11-digit product format
687889821
Labeler code
68788
Product ID
68788-9821_84fbd3f3-ab8e-4ce8-8b98-003c096b9848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA078402
Marketing category
ANDA
Marketing start
2012-04-05
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9821DDiscontinued by firm2026-08-17
excluded packagepackage68788-982168788-9821-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-982168788-9821-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-982168788-9821-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-982168788-9821-9DDiscontinued by firm2026-08-17

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 · 60 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 packagepackage68788-9821-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9821-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9821-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9821-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9821-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9821-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9821-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9821-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9821-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9821-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9821-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9821-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9821-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9821-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9821-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9821-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9821-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9821-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9821-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9821-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9821-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9821-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9821-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9821-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9821-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9821-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9821-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9821-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9821-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9821-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9821-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9821-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9821-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9821-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9821-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9821-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9821-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9821-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9821-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9821-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9821-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9821-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9821-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9821-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9821-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9821-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9821-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9821-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078402-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2007-04-19
A078402-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2007-04-19
A078402-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2007-04-19
A078402-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2007-04-19
A078402-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2007-04-19
A078402-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2007-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A078402-001AB
A078402-002AB
A078402-003AB
A078402-004AB
A078402-005AB
A078402-006AB

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078402-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-004AB103ed91905a0d…