LISINOPRIL

Product NDC
66267-578
11-digit product format
662670578
Labeler code
66267
Product ID
66267-578_9cadefca-f26a-f422-e053-2995a90abcbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202554
Marketing category
ANDA
Marketing start
2016-06-02
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
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-578IInactivated by FDA2026-10-05
excluded packagepackage66267-57866267-578-30IInactivated by FDA2026-10-05
excluded packagepackage66267-57866267-578-60IInactivated by FDA2026-10-05
excluded packagepackage66267-57866267-578-90IInactivated by FDA2026-10-05

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 2 · 72 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 packagepackage66267-578-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-578-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-578-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-578-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-578-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-578-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-578-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-578-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-578-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-578-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-578-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-578-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-578-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-578-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-578-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-578-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-578-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-578-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-578-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-578-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-578-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-578-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-578-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-578-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-578-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-578-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-578-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-578-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-578-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66267-578-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-578-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-578-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66267-578-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-578-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-578-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-578-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-578-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-578-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-578-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-578-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-578-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-578-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-578-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-578-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-578-301332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202554-001LISINOPRILLISINOPRIL2.5MGTABLET / ORAL2013-07-30
A202554-002LISINOPRILLISINOPRIL5MGTABLET / ORAL2013-07-30
A202554-003LISINOPRILLISINOPRIL10MGTABLET / ORAL2013-07-30
A202554-004LISINOPRILLISINOPRIL20MGTABLET / ORAL2013-07-30
A202554-005LISINOPRILLISINOPRIL30MGTABLET / ORAL2013-07-30
A202554-006LISINOPRILLISINOPRIL40MGTABLET / ORAL2013-07-30

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-09-14 22:38:342026-08A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-005LISINOPRIL30MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202554-006LISINOPRIL40MGTABLET / ORAL2013-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-001LISINOPRIL2.5MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-002LISINOPRIL5MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-003LISINOPRIL10MGTABLET / ORAL2013-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202554-004LISINOPRIL20MGTABLET / ORAL2013-07-30b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A202554-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202554-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202554-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202554-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202554-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202554-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202554-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202554-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202554-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202554-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202554-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202554-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202554-004AB1782e0a99824c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-578-30LISINOPRIL30 in 1 BOTTLETABLET302
66267-578-60LISINOPRIL60 in 1 BOTTLETABLET602
66267-578-90LISINOPRIL90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-578LISINOPRIL TABLET [NUCARE PHARMACEUTICALS, INC.]2Legacy NDC, 3 package rows20200122_44571f77-6bb0-3885-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN44571f77-6bb0-3885-e054-00144ff88e882
311354lisinopril 5 MG Oral TabletSCD44571f77-6bb0-3885-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-578-306626705783030 TABLET in 1 BOTTLE (66267-578-30) 30 tablet2016-12-230000-00-00NoNoCurrent
66267-578-606626705786060 TABLET in 1 BOTTLE (66267-578-60) 60 tablet2016-12-230000-00-00NoNoCurrent
66267-578-906626705789090 TABLET in 1 BOTTLE (66267-578-90) 90 tablet2016-12-230000-00-00NoNoCurrent