Lisinopril

Product NDC
61919-717
11-digit product format
619190717
Labeler code
61919
Product ID
61919-717_7ea80b2f-1cfb-0eff-e053-2a91aa0ac86e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076180
Marketing category
ANDA
Marketing start
2019-01-04
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
3 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-717IInactivated by FDA2026-08-11
excluded packagepackage61919-71761919-717-90IInactivated by FDA2026-08-11

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-717-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-717-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-717-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-717-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-717-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-717-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-717-90UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-717-90UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-717-90UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-0174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-013f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-013f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A076180-001LISINOPRIL2.5MGTABLET / ORALAB2002-07-01ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-002LISINOPRIL5MGTABLET / ORALAB2002-07-01ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-003LISINOPRIL10MGTABLET / ORALAB2002-07-01ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076180-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076180-003AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076180-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076180-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076180-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076180-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076180-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076180-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076180-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076180-003AB1ea99ee380514…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-717-902025-01-30C16284748780-12cef2736-b4ba-d83d-e063-dadaa90ab31fLisinopril

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-717-90Lisinopril90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-717-90EA - Each61919-717a41a379b-ca15-492c-a1e6-c8248c760e8f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-717LISINOPRIL TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190117_7ea80b2f-1cfa-0eff-e053-2a91aa0ac86e.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6051cc96-86e0-bd0b-e053-2a91aa0a5dcf2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILREMEDYREPACK INC.42f49299-7ae5-4d30-86eb-66b739c0e95d2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6062fd98-7663-f4b5-e053-2a91aa0acbc32026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.7e297133-669e-4780-a966-c777624e54272026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILPreferred Pharmaceuticals Inc.affd3e43-077e-42e5-a865-c961624bfe932026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILPreferred Pharmaceuticals, Inc.74415f95-74c9-4329-a6af-a0f165bf78872026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILQuality Care Products LLCbabb75f0-bccc-44e8-955a-6873344ccc212024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals, Inc.4f1f76fe-816c-384a-e054-00144ff88e882024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals, Inc.4aa518e1-d989-1fde-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals, Inc.4aa44af9-1aff-314c-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals,Inc.5a1c5b04-b78c-c057-e053-2991aa0aa9162024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals,Inc.9148529f-6278-e507-e053-2995a90aa4cf2024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILNuCare Pharmaceuticals,Inc.86e7a336-c416-6fab-e053-2a91aa0a274c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILProficient Rx LPe5fbefd1-4077-4e81-a0e3-e09fadc485932023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILA-S Medication Solutionsb5683ac4-59dc-4772-8bc6-984c698afbeb2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC2dbec080-a266-4317-8d4b-b4046206416e2022-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180
LISINOPRILLISINOPRILAphena Pharma Solutions - Tennessee, LLC6ba2c7d6-bc9e-4d8b-8d1e-c140047506932021-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076180
application number: ANDA076180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN7ea80b2f-1cfa-0eff-e053-2a91aa0ac86e1
311353lisinopril 2.5 MG Oral TabletSCD7ea80b2f-1cfa-0eff-e053-2a91aa0ac86e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-717-906191907179090 TABLET in 1 BOTTLE (61919-717-90) 90 tablet2019-01-040000-00-00NoNoCurrent