LISINOPRIL

Product NDC
55700-480
11-digit product format
557000480
Labeler code
55700
Product ID
55700-480_d3848f99-9d73-431b-adb9-139152d78bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA076164
Marketing category
ANDA
Marketing start
2017-01-13
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-480DDiscontinued by firm2026-10-05
excluded packagepackage55700-48055700-480-30DDiscontinued by firm2026-10-05
excluded packagepackage55700-48055700-480-90DDiscontinued by firm2026-10-05

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 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-48055700-480-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A076164-001LISINOPRILLISINOPRIL20MGTABLET / ORALAB2002-07-01
A076164-002LISINOPRILLISINOPRIL30MGTABLET / ORALAB2002-07-01
A076164-003LISINOPRILLISINOPRIL40MGTABLET / ORALAB2002-07-01
A076164-004LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2002-07-01
A076164-005LISINOPRILLISINOPRIL5MGTABLET / ORALAB2002-07-01
A076164-006LISINOPRILLISINOPRIL10MGTABLET / ORALAB2002-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A076164-001AB
A076164-002AB
A076164-003AB
A076164-004AB
A076164-005AB
A076164-006AB

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 · 243 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 243 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076164-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A076164-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A076164-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076164-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076164-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076164-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076164-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076164-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076164-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076164-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076164-004AB1b8a1b40f171c…

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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-480-30LISINOPRIL30 in 1 BOTTLETABLET30119
55700-480-90LISINOPRIL90 in 1 BOTTLETABLET90119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-480-30EA - Each55700-48093e3ebb0-af4b-4d10-8676-bf96c2cb531e12017-06-15
55700-480-90EA - Each55700-480156563a3-0290-4bdc-a64a-1b5128247b2012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-480LISINOPRIL TABLET [QUALITY CARE PRODUCTS LLC]119Legacy NDC, 2 package rows20241219_babb75f0-bccc-44e8-955a-6873344ccc21.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LISINOPRILLISINOPRILNorthwind Health Company, LLCdb98aaba-5925-f81b-e053-2a95a90a48792026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILQPharma, Inc.cfd31165-5902-4c94-8fff-2940faa983c12025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILQPharma, Inc.c3bcfcae-a9ab-4a57-876d-8749ab6c2cff2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILQPharma, Inc.bd436b8b-98a6-584c-e053-2995a90ac15d2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.705582ed-da8c-418f-8bb2-fc0b74ed0a882025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILBryant Ranch Prepacka0b068b4-1e55-446b-912b-3534e9e6fb752025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutionsa881df2d-e3b7-413f-b4bb-2c3d917b08112025-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILA-S Medication Solutionsd81deeaf-7e5e-44c5-9348-5923c4e3ccd62025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILAsclemed USA, Inc.db5bfa2f-07b8-4f79-8a40-691da006e2ed2025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.bf59ff89-a9fa-4fe3-b167-a5d0cba9e4382025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.03a497fe-fb09-4b2c-8ee0-2019600192b82025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.dd015c18-1ea6-44e3-9186-8d2f8444d8742025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILPD-Rx Pharmaceuticals, Inc.e4c11545-00da-4675-856a-7e600a2f4bd92025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILQuality Care Products LLC29e9ac54-f9da-495c-9102-2aac2cc7d88a2024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILQuality Care Products LLCbabb75f0-bccc-44e8-955a-6873344ccc212024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 55700-480
LISINOPRILLISINOPRILA-S Medication Solutions8f63c3e0-0b3f-4a04-a592-2ce10dfda2022024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILBryant Ranch Prepack06ca101e-4498-4c4e-b455-01915e7ecca02024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILBryant Ranch Prepack24f532f2-c41e-4d1d-989e-7a56b60fbdd42024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILBryant Ranch Prepack0bf433cb-bf7d-4b41-9518-400646f9aa2a2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164
LISINOPRILLISINOPRILBryant Ranch Prepackbebf037f-10f8-4e1f-a512-614f81deb8912024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNbabb75f0-bccc-44e8-955a-6873344ccc21119
314077lisinopril 20 MG Oral TabletPSNbabb75f0-bccc-44e8-955a-6873344ccc21119
314076lisinopril 10 MG Oral TabletSCDbabb75f0-bccc-44e8-955a-6873344ccc21119
314077lisinopril 20 MG Oral TabletSCDbabb75f0-bccc-44e8-955a-6873344ccc21119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-480-305570004803030 TABLET in 1 BOTTLE (55700-480-30) 30 tablet2017-02-060000-00-00NoNoCurrent
55700-480-905570004809090 TABLET in 1 BOTTLE (55700-480-90) 90 tablet2017-01-130000-00-00NoNoCurrent