Lisinopril

Product NDC
53217-253
11-digit product format
532170253
Labeler code
53217
Product ID
53217-253_069bd16d-3af5-4385-8843-f079cd0f6e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076063
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
20 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 productproduct53217-253IInactivated by FDA2026-08-17
excluded packagepackage53217-25353217-253-02IInactivated by FDA2026-08-17
excluded packagepackage53217-25353217-253-30IInactivated by FDA2026-08-17
excluded packagepackage53217-25353217-253-60IInactivated by FDA2026-08-17
excluded packagepackage53217-25353217-253-90IInactivated 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 2 · 105 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 packagepackage53217-253-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-253-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-253-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-253-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-253-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-253-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-253-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-253-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-253-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-253-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-253-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-253-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-253-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-253-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-253-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-253-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-253-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-253-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-253-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-253-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-253-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-253-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-253-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-253-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-253-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-253-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-253-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-253-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-253-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-253-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-253-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-253-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-253-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-253-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-253-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-253-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-253-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-253-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-253-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-253-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-253-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-253-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-253-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-253-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-253-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-253-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-253-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-253-30557ba5c1ecfa…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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-253-02Lisinopril120 in 1 BOTTLETABLET1201
53217-253-30Lisinopril30 in 1 BOTTLETABLET301
53217-253-60Lisinopril60 in 1 BOTTLETABLET601
53217-253-90Lisinopril90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-253-02EA - Each53217-2535bb27b11-a04c-421a-9fa6-aef82130d2dd12016-12-07
53217-253-30EA - Each53217-2538889dadb-ef15-4550-9241-fa51560d21fd12016-12-07
53217-253-60EA - Each53217-2539ec27bc7-a705-44e7-8c9f-ed25cac0d8c812016-12-07
53217-253-90EA - Each53217-253add78c03-2544-48e0-91c2-409213d88a4a12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-253LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161111_bb6ec726-a143-4811-be3c-1a404459dee6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSNbb6ec726-a143-4811-be3c-1a404459dee61
314077lisinopril 20 MG Oral TabletSCDbb6ec726-a143-4811-be3c-1a404459dee61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-253-0253217025302120 in 1 BOTTLEHistorical
53217-253-305321702533030 in 1 BOTTLEHistorical
53217-253-605321702536060 in 1 BOTTLEHistorical
53217-253-905321702539090 in 1 BOTTLEHistorical