FDA.reportPublic FDA data

Lisinopril

Product NDC
69117-0038
11-digit product format
691170038
Labeler code
69117
Product ID
69117-0038_d62739e8-a663-5771-e053-2995a90a066a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA212041
Marketing category
ANDA
Marketing start
2020-09-15
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
69117-0038-12025-01-30C16284748780-12cef2736-8990-d83d-e063-dadaa90ab31fLisinopril tablets Yiling Pharmaceutical Ltd --------------- These 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
69117-0038-22025-01-30C16284748780-12cef2736-8990-d83d-e063-dadaa90ab31fLisinopril tablets Yiling Pharmaceutical Ltd --------------- These 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
69117-0038-32025-01-30C16284748780-12cef2736-8990-d83d-e063-dadaa90ab31fLisinopril tablets Yiling Pharmaceutical Ltd --------------- These 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
69117-0038-42025-01-30C16284748780-12cef2736-8990-d83d-e063-dadaa90ab31fLisinopril tablets Yiling Pharmaceutical Ltd --------------- These 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
69117-0038-52025-01-30C16284748780-12cef2736-8990-d83d-e063-dadaa90ab31fLisinopril tablets Yiling Pharmaceutical Ltd --------------- These 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
69117-0038-1Lisinopril30 in 1 BOTTLETABLET305
69117-0038-2Lisinopril90 in 1 BOTTLETABLET905
69117-0038-3Lisinopril100 in 1 BOTTLETABLET1005
69117-0038-4Lisinopril500 in 1 BOTTLETABLET5005
69117-0038-5Lisinopril1000 in 1 BOTTLETABLET10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0038LISINOPRIL TABLET [YILING PHARMACEUTICAL, INC.]5Legacy NDC, 5 package rows20230706_b2e928d0-1dfb-4dc0-8c62-ca4fc1f92228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
311353lisinopril 2.5 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
314077lisinopril 20 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
205326lisinopril 30 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
197884lisinopril 40 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
311354lisinopril 5 MG Oral TabletPSNb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
314076lisinopril 10 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
311353lisinopril 2.5 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
314077lisinopril 20 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
205326lisinopril 30 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
197884lisinopril 40 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285
311354lisinopril 5 MG Oral TabletSCDb2e928d0-1dfb-4dc0-8c62-ca4fc1f922285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0038-16911700380130 TABLET in 1 BOTTLE (69117-0038-1) 30 tablet2019-12-310000-00-00NoNoCurrent
69117-0038-26911700380290 TABLET in 1 BOTTLE (69117-0038-2) 90 tablet2019-12-310000-00-00NoNoCurrent
69117-0038-369117003803100 TABLET in 1 BOTTLE (69117-0038-3) 100 tablet2020-09-150000-00-00NoNoCurrent
69117-0038-469117003804500 TABLET in 1 BOTTLE (69117-0038-4) 500 tablet2020-09-150000-00-00NoNoCurrent
69117-0038-5691170038051000 TABLET in 1 BOTTLE (69117-0038-5) 1000 tablet2020-09-150000-00-00NoNoCurrent