FDA.reportPublic FDA data

Lisinopril

Product NDC
53217-253
11-digit product format
532170253
Labeler code
53217
Product ID
53217-253_069bd16d-3af5-4385-8843-f079cd0f6e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076063
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-253-022020-01-31C16284748780-19d75b9d1-11b8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988
53217-253-302020-01-31C16284748780-19d75b9d1-11b8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988
53217-253-602020-01-31C16284748780-19d75b9d1-11b8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988
53217-253-902020-01-31C16284748780-19d75b9d1-11b8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LISINOPRIL TABLETS, USP safely and effectively. See full prescribing information for LISINOPRIL TABLETS, USP . LISINOPRIL tablets , for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-253-02Lisinopril120 in 1 BOTTLETABLET1201
53217-253-30Lisinopril30 in 1 BOTTLETABLET301
53217-253-60Lisinopril60 in 1 BOTTLETABLET601
53217-253-90Lisinopril90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-253-02EA - Each53217-2535bb27b11-a04c-421a-9fa6-aef82130d2dd12016-12-07
53217-253-30EA - Each53217-2538889dadb-ef15-4550-9241-fa51560d21fd12016-12-07
53217-253-60EA - Each53217-2539ec27bc7-a705-44e7-8c9f-ed25cac0d8c812016-12-07
53217-253-90EA - Each53217-253add78c03-2544-48e0-91c2-409213d88a4a12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-253LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20161111_bb6ec726-a143-4811-be3c-1a404459dee6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSNbb6ec726-a143-4811-be3c-1a404459dee61
314077lisinopril 20 MG Oral TabletSCDbb6ec726-a143-4811-be3c-1a404459dee61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-253-0253217025302120 in 1 BOTTLEHistorical
53217-253-305321702533030 in 1 BOTTLEHistorical
53217-253-605321702536060 in 1 BOTTLEHistorical
53217-253-905321702539090 in 1 BOTTLEHistorical