Lisinopril

Product NDC
55154-5053
11-digit product format
551545053
Labeler code
55154
Product ID
55154-5053_f969927e-0872-42f4-8f9e-7970a7c792d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076071
Marketing category
ANDA
Marketing start
2012-08-27
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
2020-12-31
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 productproduct55154-5053DDiscontinued by firm2026-08-17
excluded packagepackage55154-505355154-5053-0DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage55154-5053-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-5053-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55154-5053-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55154-5053-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55154-5053-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55154-5053-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55154-5053-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55154-5053-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55154-5053-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-5053-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-5053-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55154-5053-0557ba5c1ecfa…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
A076071-001LISINOPRILLISINOPRIL2.5MGTABLET / ORAL2002-07-01
A076071-002LISINOPRILLISINOPRIL5MGTABLET / ORAL2002-07-01
A076071-003LISINOPRILLISINOPRIL10MGTABLET / ORAL2002-07-01
A076071-004LISINOPRILLISINOPRIL20MGTABLET / ORAL2002-07-01
A076071-005LISINOPRILLISINOPRIL30MGTABLET / ORAL2002-07-01
A076071-006LISINOPRILLISINOPRIL40MGTABLET / ORAL2002-07-01

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 06:07:402026-07A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-005LISINOPRIL30MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076071-006LISINOPRIL40MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076071-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076071-002LISINOPRIL5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076071-003LISINOPRIL10MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076071-004LISINOPRIL20MGTABLET / ORAL2002-07-0103ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A076071-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076071-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076071-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076071-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076071-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076071-006AB1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [CARDINAL HEALTH]10
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [CARDINAL HEALTH]10
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [CARDINAL HEALTH]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LISINOPRIL TABLET [CARDINAL HEALTH]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLISINOPRIL TABLET [CARDINAL HEALTH]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL TABLET [CARDINAL HEALTH]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LISINOPRIL TABLET [CARDINAL HEALTH]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [CARDINAL HEALTH]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [CARDINAL HEALTH]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [CARDINAL HEALTH]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [CARDINAL HEALTH]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLISINOPRIL TABLET [CARDINAL HEALTH]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [CARDINAL HEALTH]10