Lisinopril

Product NDC
71610-726
Requested package NDC
71610-726-70
11-digit product format
716100726
Labeler code
71610
Product ID
71610-726_03a22769-c7ac-496c-80c4-98f76c371987
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077321
Marketing category
ANDA
Marketing start
2006-01-13
Substance
LISINOPRIL
Active strength
2.5 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
A077321-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2005-09-09
A077321-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2005-09-09
A077321-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2005-09-09
A077321-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2005-09-09
A077321-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2005-09-09
A077321-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2005-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077321-001AB
A077321-002AB
A077321-003AB
A077321-004AB
A077321-005AB
A077321-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-09b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077321-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A077321-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A077321-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077321-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077321-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077321-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077321-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077321-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077321-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077321-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-004AB1b8a1b40f171c…

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
LISINOPRIL2.5 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
311353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
021831ab-dfeb-40fc-aede-4aa1fbb8d918Available 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
71610-726-30Lisinopril30 in 1 BOTTLETABLET301
71610-726-45Lisinopril45 in 1 BOTTLETABLET451
71610-726-53Lisinopril60 in 1 BOTTLETABLET601
71610-726-60Lisinopril90 in 1 BOTTLETABLET901
71610-726-70Lisinopril120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-726-30EA - Each71610-7269cc85309-1c5e-413c-aa8f-901d4ccc888f12023-10-16
71610-726-45EA - Each71610-726de5c93ed-09d1-463a-bf69-c36ef13d359f12023-10-16
71610-726-53EA - Each71610-726498f1ad0-fda2-4944-b8ac-9d1205409e7712023-10-16
71610-726-60EA - Each71610-7262c236e87-25c0-45a9-a33e-32af02425b0312023-10-16
71610-726-70EA - Each71610-726ec8ee9b1-4648-4418-be48-4fa407a68e8c12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-726LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20230819_021831ab-dfeb-40fc-aede-4aa1fbb8d918.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 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILREMEDYREPACK INC.aa5d68e7-c2b9-41eb-ade4-2cd57edc15332026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.a33d860a-1e17-45b7-aede-51ab3223bebd2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILA-S Medication Solutions88b5a2c0-6ad2-48e7-9ffe-715d9159f3892026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILA-S Medication Solutions34953f77-bae1-41fe-af11-3ea0b3ceaa112026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.3451292b-7867-4dc2-afaa-da66b40160172026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.d32923fe-a323-43c6-af46-bcba7274b0bf2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.551665a0-9a92-55df-e063-6394a90a1e2e2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55189717-f5db-9c63-e063-6294a90a6bc92026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILUnit Dose Solutions, Inc.55191baa-f812-2e71-e063-6294a90a8edf2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILPD-Rx Pharmaceuticals, Inc.c621c33b-cb67-4ea6-b2bd-96c20a244ea42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC538429b8-4f10-e825-e063-6294a90a59052026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCardinal Health 107, LLC1d0caa63-9ea2-4a97-a23b-900a7c514bc62026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC518a63e3-8ca1-bbd1-e063-6294a90aa5242026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILCoupler LLC509a46cf-7a89-b6c0-e063-6394a90a75092026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILBryant Ranch Prepack08b0555e-41d2-44c3-b27b-ad5d701378dc2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILBryant Ranch Prepack59fd2167-4da4-9143-83bd-3b6aa50515112026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.a35079fa-b693-45e8-9715-488e33e7c1a92026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321
LisinoprilLISINOPRILREMEDYREPACK INC.f22bfb4d-dda6-4c7f-a485-cfb7710ef3de2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN021831ab-dfeb-40fc-aede-4aa1fbb8d9181
311353lisinopril 2.5 MG Oral TabletSCD021831ab-dfeb-40fc-aede-4aa1fbb8d9181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-726-7071610072670120 TABLET in 1 BOTTLE (71610-726-70) 120 tablet2023-08-17NoNoCurrent