LISINOPRIL

Product NDC
71335-0015
11-digit product format
713350015
Labeler code
71335
Product ID
71335-0015_4ab3e615-46ea-4ed4-b21f-3cd5382fb9b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 249 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076164-001LISINOPRIL20MGTABLET / ORALAB2002-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A076164-002LISINOPRIL30MGTABLET / ORALAB2002-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A076164-003LISINOPRIL40MGTABLET / ORALAB2002-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A076164-004LISINOPRIL2.5MGTABLET / ORALAB2002-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A076164-005LISINOPRIL5MGTABLET / ORALAB2002-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A076164-006LISINOPRIL10MGTABLET / ORALAB2002-07-01c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 249 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A076164-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A076164-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A076164-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A076164-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A076164-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09A076164-006AB1c2088c7a36db…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E7199S1YWRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314077Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06ca101e-4498-4c4e-b455-01915e7ecca0Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0015-0LISINOPRIL7 in 1 BOTTLETABLET720
71335-0015-1LISINOPRIL30 in 1 BOTTLETABLET3020
71335-0015-2LISINOPRIL60 in 1 BOTTLETABLET6020
71335-0015-3LISINOPRIL90 in 1 BOTTLETABLET9020
71335-0015-4LISINOPRIL100 in 1 BOTTLETABLET10020
71335-0015-5LISINOPRIL200 in 1 BOTTLETABLET20020
71335-0015-6LISINOPRIL120 in 1 BOTTLETABLET12020
71335-0015-7LISINOPRIL20 in 1 BOTTLETABLET2020
71335-0015-8LISINOPRIL10 in 1 BOTTLETABLET1020
71335-0015-9LISINOPRIL180 in 1 BOTTLETABLET18020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0015-1EA - Each71335-0015b504ca7b-ba23-491a-8d2b-fd0c58c3d31112018-03-08
71335-0015-2EA - Each71335-001594d31e72-3a01-4ec9-945a-6d38a1d2b4c612018-03-08
71335-0015-3EA - Each71335-00156aef214f-4021-46ab-8a9d-80c8c1bcf6d312018-03-08
71335-0015-4EA - Each71335-0015d6d8268a-f8e1-494d-9cc3-2ff19c5f697112018-03-08
71335-0015-5EA - Each71335-0015d6874414-31ad-476a-ab5a-55a58d72287e12018-03-08
71335-0015-6EA - Each71335-0015c19f9970-2079-446f-89af-1b278631a29912018-03-08
71335-0015-7EA - Each71335-0015f2479710-6c7d-4087-995e-a049db57c22012018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0015LISINOPRIL TABLET [BRYANT RANCH PREPACK]20Current NDC, Legacy NDC, 10 package rows20241024_06ca101e-4498-4c4e-b455-01915e7ecca0.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 · 50 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
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
ndc (product): 71335-0015
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
LISINOPRILLISINOPRILBryant Ranch Prepack37aa2542-de44-401b-a6ff-96d2e07914c72024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076164
application number: ANDA076164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSN06ca101e-4498-4c4e-b455-01915e7ecca020
314077lisinopril 20 MG Oral TabletSCD06ca101e-4498-4c4e-b455-01915e7ecca020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0015-0713350015007 TABLET in 1 BOTTLE (71335-0015-0) 7 tablet2024-10-08NoNoCurrent
71335-0015-17133500150130 TABLET in 1 BOTTLE (71335-0015-1) 30 tablet2018-04-090000-00-00NoNoCurrent
71335-0015-27133500150260 TABLET in 1 BOTTLE (71335-0015-2) 60 tablet2018-09-170000-00-00NoNoCurrent
71335-0015-37133500150390 TABLET in 1 BOTTLE (71335-0015-3) 90 tablet2018-03-130000-00-00NoNoCurrent
71335-0015-471335001504100 TABLET in 1 BOTTLE (71335-0015-4) 100 tablet2018-06-260000-00-00NoNoCurrent
71335-0015-571335001505200 TABLET in 1 BOTTLE (71335-0015-5) 200 tablet2018-03-020000-00-00NoNoCurrent
71335-0015-671335001506120 TABLET in 1 BOTTLE (71335-0015-6) 120 tablet2018-11-160000-00-00NoNoCurrent
71335-0015-77133500150720 TABLET in 1 BOTTLE (71335-0015-7) 20 tablet2019-06-280000-00-00NoNoCurrent
71335-0015-87133500150810 TABLET in 1 BOTTLE (71335-0015-8) 10 tablet2024-10-080000-00-00NoNoCurrent
71335-0015-971335001509180 TABLET in 1 BOTTLE (71335-0015-9) 180 tablet2021-11-090000-00-00NoNoCurrent