LISINOPRIL

Product NDC
50436-0353
11-digit product format
504360353
Labeler code
50436
Product ID
50436-0353_c4d985d0-4007-4f6a-87d4-60f8a00254c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076180
Marketing category
ANDA
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-0353IInactivated by FDA2026-08-11
excluded packagepackage50436-035350436-0353-1IInactivated by FDA2026-08-11
excluded packagepackage50436-035350436-0353-3IInactivated 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 · 54 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 packagepackage50436-0353-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-0353-1IInactivated 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 packagepackage50436-0353-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-0353-1IInactivated 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 packagepackage50436-0353-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-0353-1IInactivated 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 packagepackage50436-0353-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-0353-1IInactivated 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 packagepackage50436-0353-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-0353-1IInactivated 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 packagepackage50436-0353-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-0353-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0353-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-0353-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0353-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-0353-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0353-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-0353-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0353-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-0353-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0353-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-0353-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0353-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-0353-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0353-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-0353-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0353-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-0353-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0353-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-0353-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductEExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-0353-3EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-0353-1EExcluded after deficient or non-compliant submission was not correctedfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductEExcluded after deficient or non-compliant submission was not corrected86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-0353-3EExcluded after deficient or non-compliant submission was not corrected86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-0353-1EExcluded after deficient or non-compliant submission was not corrected86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductEExcluded after deficient or non-compliant submission was not correctedbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-0353-3EExcluded after deficient or non-compliant submission was not correctedbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-0353-1EExcluded after deficient or non-compliant submission was not correctedbd6a592717d7…303034d00443…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0353-1LISINOPRIL24 in 1 BOTTLETABLET2418
50436-0353-3LISINOPRIL90 in 1 BOTTLETABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0353LISINOPRIL TABLET [UNIT DOSE SERVICES]18Legacy NDC, 2 package rows20230110_e65f2d8c-a4f6-40ba-a85d-8ee7806bd65f.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
314076lisinopril 10 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314077lisinopril 20 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
311354lisinopril 5 MG Oral TabletPSNe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314076lisinopril 10 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
314077lisinopril 20 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18
311354lisinopril 5 MG Oral TabletSCDe65f2d8c-a4f6-40ba-a85d-8ee7806bd65f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0353-15043603530124 TABLET in 1 BOTTLE (50436-0353-1) 24 tablet2021-10-120000-00-00NoNoCurrent
50436-0353-35043603530390 TABLET in 1 BOTTLE (50436-0353-3) 90 tablet2018-09-270000-00-00NoNoCurrent