Lisinopril

Product NDC
0440-7674
11-digit product format
004407674
Labeler code
0440
Product ID
0440-7674_5882cbb4-7d17-4c90-aff3-db64a7831f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA078402
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct0440-7674IInactivated by FDA2026-08-17
excluded packagepackage0440-76740440-7674-90IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-7674-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-7674-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-7674-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-7674-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-7674-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-7674-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-7674-90IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-7674-90IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0440-7674-90IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0440-7674-90IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0440-7674-90IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0440-7674-90IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0440-7674-90IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0440-7674-90IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0440-7674-90IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0440-7674-90IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0440-7674-90IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0440-7674-90IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0440-7674-90IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0440-7674-90IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0440-7674-90IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0440-7674-90EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-7674-902020-01-31C16284748780-19d75b9d0-d2e8-f424-e053-dadaa90a57ceLisinopril Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7674-90Lisinopril90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7674LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20140404_19563d4f-d5dc-4fa5-a354-f2203bd64c71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN19563d4f-d5dc-4fa5-a354-f2203bd64c712
311354lisinopril 5 MG Oral TabletSCD19563d4f-d5dc-4fa5-a354-f2203bd64c712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7674-900044076749090 in 1 BOTTLE, PLASTICHistorical