FDA.reportPublic FDA data

LISINOPRIL

Product NDC
53217-303
11-digit product format
532170303
Labeler code
53217
Product ID
53217-303_61ae0a56-8ad4-4a7f-bf2a-5017e06322e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
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
53217-303-022020-01-31C16284748780-19d75b9d0-3259-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
53217-303-302020-01-31C16284748780-19d75b9d0-3259-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
53217-303-602020-01-31C16284748780-19d75b9d0-3259-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988
53217-303-902020-01-31C16284748780-19d75b9d0-3259-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Lisinopril safely and effectively. See full prescribing information for Lisinopril LISINOPRIL tablets USP, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-303-02LISINOPRIL120 in 1 BOTTLETABLET1201
53217-303-30LISINOPRIL30 in 1 BOTTLETABLET301
53217-303-60LISINOPRIL60 in 1 BOTTLETABLET601
53217-303-90LISINOPRIL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-303-02EA - Each53217-3032ad24ceb-adeb-4d93-9c79-fec5d6a6c4b412017-07-07
53217-303-30EA - Each53217-30300d93437-917f-48aa-9d53-6e6ca713049c12017-07-07
53217-303-60EA - Each53217-303bd279d5a-3fde-4d84-b4ee-647e4808bf0a12017-07-07
53217-303-90EA - Each53217-30376a51a5d-8281-4db7-a288-6d5fa447781612017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-303LISINOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20170616_99062133-2593-440e-911e-904195faba43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN99062133-2593-440e-911e-904195faba431
314076lisinopril 10 MG Oral TabletSCD99062133-2593-440e-911e-904195faba431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-303-0253217030302120 in 1 BOTTLEHistorical
53217-303-305321703033030 in 1 BOTTLEHistorical
53217-303-605321703036060 in 1 BOTTLEHistorical
53217-303-905321703039090 in 1 BOTTLEHistorical