FDA.reportPublic FDA data

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

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
50436-0353-12024-01-30C16284748780-1ba0f9c33-5630-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-32024-01-30C16284748780-1ba0f9c33-5630-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-32021-10-22C16284748780-1ba0f9c33-5630-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
50436-0353-32021-01-29C16284748780-1ba0f9c33-5630-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

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

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