Lisinopril

Product NDC
67046-424
Requested package NDC
67046-424-30
11-digit product format
670460424
Labeler code
67046
Product ID
67046-424_bcd14bc6-b6c5-495b-e053-2995a90a67e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077321
Marketing category
ANDA
Marketing start
2017-01-01
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-42467046-424-30IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-005LISINOPRIL30MGTABLET / ORALAB2005-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-006LISINOPRIL40MGTABLET / ORALAB2005-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-001LISINOPRIL2.5MGTABLET / ORALAB2005-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-002LISINOPRIL5MGTABLET / ORALAB2005-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-003LISINOPRIL10MGTABLET / ORALAB2005-09-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-004LISINOPRIL20MGTABLET / ORALAB2005-09-092680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077321-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077321-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077321-004AB12680178bc6a6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-424-30Lisinopril30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-424LISINOPRIL TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20210308_bcd14c33-e2c1-85ca-e053-2995a90a4efa.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 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-07-02Boxed 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
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-04-06Boxed 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
LisinoprilLISINOPRILREMEDYREPACK INC.efc9eb3c-0f54-47b8-b236-8680e0046ea42026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077321
application number: ANDA077321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSNbcd14c33-e2c1-85ca-e053-2995a90a4efa1
311354lisinopril 5 MG Oral TabletSCDbcd14c33-e2c1-85ca-e053-2995a90a4efa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-424-306704604243030 TABLET in 1 BLISTER PACK (67046-424-30) 30 tablet2017-01-010000-00-00NoNoCurrent