lisinopril

Product NDC
53808-0999
11-digit product format
538080999
Labeler code
53808
Product ID
53808-0999_0b20f104-54f1-4197-bbdf-0cfe9304396c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA075994
Marketing category
ANDA
Marketing start
2014-11-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0999IInactivated by FDA2026-08-03
excluded packagepackage53808-099953808-0999-2IInactivated by FDA2026-08-03

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 · 42 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 packagepackage53808-0999-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0999-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0999-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0999-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0999-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0999-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0999-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0999-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0999-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0999-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0999-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0999-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0999-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0999-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0999-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0999-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0999-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0999-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0999-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0999-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0999-29bebd1f3094a…5416666fcb17…

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

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
A075994-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-07-01
A075994-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-07-01
A075994-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2002-07-01
A075994-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-07-01
A075994-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-07-01
A075994-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2002-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075994-001AB
A075994-002AB
A075994-003AB
A075994-004AB
A075994-005AB
A075994-006AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-005LISINOPRIL30MGTABLET / ORALAB2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-006LISINOPRIL40MGTABLET / ORALAB2002-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-002LISINOPRIL5MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-003LISINOPRIL10MGTABLET / ORALAB2002-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-004LISINOPRIL20MGTABLET / ORALAB2002-07-012680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075994-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075994-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075994-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075994-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075994-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075994-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075994-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075994-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075994-004AB12680178bc6a6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0999-22020-01-31C16284748780-19d75b9d0-2c62-f424-e053-dadaa90a57ceLisinopril Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0999-2lisinopril60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0999LISINOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150113_7885537f-88b2-4d39-bcd2-cad9b2e5fbe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSN7885537f-88b2-4d39-bcd2-cad9b2e5fbe51
197884lisinopril 40 MG Oral TabletSCD7885537f-88b2-4d39-bcd2-cad9b2e5fbe51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0999-25380809990260 in 1 BLISTER PACKHistorical