Lisinopril

Product NDC
51138-068
11-digit product format
511380068
Labeler code
51138
Product ID
51138-068_fd8130de-c98c-4485-9e3e-93a19f20ab87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
ANDA076063
Marketing category
ANDA
Marketing start
2011-01-05
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
E
Listing certified through
2017-12-31
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 productproduct51138-068IInactivated by FDA2026-08-17
excluded packagepackage51138-06851138-068-30IInactivated by FDA2026-08-17

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 · 44 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 packagepackage51138-068-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51138-068-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51138-068-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51138-068-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51138-068-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51138-068-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51138-068-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51138-068-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51138-068-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51138-068-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51138-068-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51138-068-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51138-068-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51138-068-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51138-068-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51138-068-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51138-068-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51138-068-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51138-068-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51138-068-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51138-068-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51138-068-30110d247fa046…a55b01930146…

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
A076063-001LISINOPRILLISINOPRIL2.5MGTABLET / ORAL2002-07-01
A076063-002LISINOPRILLISINOPRIL5MGTABLET / ORAL2002-07-01
A076063-003LISINOPRILLISINOPRIL10MGTABLET / ORAL2002-07-01
A076063-004LISINOPRILLISINOPRIL20MGTABLET / ORAL2002-07-01
A076063-005LISINOPRILLISINOPRIL40MGTABLET / ORAL2002-07-01
A076063-006LISINOPRILLISINOPRIL30MGTABLET / ORAL2003-06-27

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 06:07:402026-07A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-0103ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076063-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-006AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076063-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076063-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076063-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-006AB1ea99ee380514…

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
51138-068-302019-11-27C16284748780-19855d018-e4e0-cd31-e053-dbdaa90ab51aLISINOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-068-30Lisinopril30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-068-30EA - Each51138-0680657d97b-db8e-4d4b-adb0-7a14306d2f3712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-068LISINOPRIL TABLET [MED-HEALTH PHARMA, LLC]2Legacy NDC, 1 package rows20130418_c7e7d939-8f5c-4443-b6cf-c306e06ddf67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311353lisinopril 2.5 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314077lisinopril 20 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
205326lisinopril 30 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
197884lisinopril 40 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311354lisinopril 5 MG Oral TabletPSNc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314076lisinopril 10 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311353lisinopril 2.5 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
314077lisinopril 20 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
205326lisinopril 30 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
197884lisinopril 40 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672
311354lisinopril 5 MG Oral TabletSCDc7e7d939-8f5c-4443-b6cf-c306e06ddf672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-068-305113800683030 in 1 BOTTLE, PLASTICHistorical