FDA.reportPublic FDA data

LISINOPRIL

Product NDC
68071-3123
11-digit product format
680713123
Labeler code
68071
Product ID
68071-3123_1d9eaa76-8491-a471-e063-6394a90aef30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA076180
Marketing category
ANDA
Marketing start
2011-11-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3123-32021-02-11C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-62021-02-11C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-92021-02-11C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-32021-01-29C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-62021-01-29C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-92021-01-29C16284748780-1ba0f9c33-4eaa-a910-e053-dadaa90a0b85These 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
68071-3123-1LISINOPRIL120 in 1 BOTTLETABLET1207
68071-3123-3LISINOPRIL30 in 1 BOTTLETABLET307
68071-3123-6LISINOPRIL60 in 1 BOTTLETABLET607
68071-3123-9LISINOPRIL90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3123LISINOPRIL TABLET [NUCARE PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20240720_4aa44af9-1aff-314c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSN4aa44af9-1aff-314c-e054-00144ff8d46c7
311354lisinopril 5 MG Oral TabletSCD4aa44af9-1aff-314c-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3123-168071312301120 TABLET in 1 BOTTLE (68071-3123-1) 120 tablet2017-03-130000-00-00NoNoCurrent
68071-3123-36807131230330 TABLET in 1 BOTTLE (68071-3123-3) 30 tablet2017-03-130000-00-00NoNoCurrent
68071-3123-66807131230660 TABLET in 1 BOTTLE (68071-3123-6) 60 tablet2017-03-130000-00-00NoNoCurrent
68071-3123-96807131230990 TABLET in 1 BOTTLE (68071-3123-9) 90 tablet2017-03-130000-00-00NoNoCurrent