LISINOPRIL

Product NDC
53002-1225
11-digit product format
530021225
Labeler code
53002
Product ID
53002-1225_fe7c7b6c-e0da-4802-9af0-d84dca3d2eb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076180
Marketing category
ANDA
Marketing start
2011-11-01
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
2021-12-31
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
53002-1225-02025-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-32025-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-62025-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-02023-06-07C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-32023-06-07C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-62023-06-07C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-02023-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-32023-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-62023-01-30C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-02020-12-16C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-32020-12-16C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-62020-12-16C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-02020-01-31C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-32020-01-31C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-62020-01-31C16284748780-19d75b9cf-f140-f424-e053-dadaa90a57ceThese 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
53002-1225-0LISINOPRIL100 in 1 BOTTLETABLET10014
53002-1225-3LISINOPRIL30 in 1 BOTTLETABLET3014
53002-1225-6LISINOPRIL60 in 1 BOTTLETABLET6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1225LISINOPRIL TABLET [RPK PHARMACEUTICALS, INC.]14Legacy NDC, 3 package rows20230609_9c03eb4a-aa58-44a8-82d4-669c880a6f45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314077lisinopril 20 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
197884lisinopril 40 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
311354lisinopril 5 MG Oral TabletPSN9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314076lisinopril 10 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
314077lisinopril 20 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
197884lisinopril 40 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514
311354lisinopril 5 MG Oral TabletSCD9c03eb4a-aa58-44a8-82d4-669c880a6f4514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1225-053002122500100 TABLET in 1 BOTTLE (53002-1225-0) 100 tablet2018-10-020000-00-00NoNoCurrent
53002-1225-35300212250330 TABLET in 1 BOTTLE (53002-1225-3) 30 tablet2018-10-020000-00-00NoNoCurrent
53002-1225-65300212250660 TABLET in 1 BOTTLE (53002-1225-6) 60 tablet2018-10-020000-00-00NoNoCurrent