LISINOPRIL

Product NDC
68071-3064
11-digit product format
680713064
Labeler code
68071
Product ID
68071-3064_1d8e4c5c-500f-be32-e063-6294a90a6f87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LISINOPRIL
Active strength
40 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 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.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL40 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
197884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6314e49c-8715-2f01-e053-2a91aa0ab2a5Available 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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-3064-32021-02-11These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-52021-02-11These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-62021-02-11These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-82021-02-11These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-92021-02-11These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-32021-01-29These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-52021-01-29These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-62021-01-29These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-82021-01-29These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
68071-3064-92021-01-29These highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3064-2LISINOPRIL120 in 1 BOTTLETABLET1206
68071-3064-3LISINOPRIL30 in 1 BOTTLETABLET306
68071-3064-5LISINOPRIL45 in 1 BOTTLETABLET456
68071-3064-6LISINOPRIL60 in 1 BOTTLETABLET606
68071-3064-8LISINOPRIL180 in 1 BOTTLETABLET1806
68071-3064-9LISINOPRIL90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3064LISINOPRIL TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 6 package rows20240720_6314e49c-8715-2f01-e053-2a91aa0ab2a5.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
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
197884lisinopril 40 MG Oral TabletPSN6314e49c-8715-2f01-e053-2a91aa0ab2a56
197884lisinopril 40 MG Oral TabletSCD6314e49c-8715-2f01-e053-2a91aa0ab2a56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3064-268071306402120 TABLET in 1 BOTTLE (68071-3064-2) 120 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-36807130640330 TABLET in 1 BOTTLE (68071-3064-3) 30 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-56807130640545 TABLET in 1 BOTTLE (68071-3064-5) 45 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-66807130640660 TABLET in 1 BOTTLE (68071-3064-6) 60 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-868071306408180 TABLET in 1 BOTTLE (68071-3064-8) 180 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-96807130640990 TABLET in 1 BOTTLE (68071-3064-9) 90 tablet2018-01-180000-00-00NoNoCurrent