LISINOPRIL

Product NDC
68071-3064
11-digit product format
680713064
Labeler code
68071
Product ID
68071-3064_1d8e4c5c-500f-be32-e063-6294a90a6f87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LISINOPRIL
Active strength
40 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
LISINOPRIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884

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
68071-3064-32021-02-11C16284748780-1ba0f9c33-5850-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
68071-3064-52021-02-11C16284748780-1ba0f9c33-5850-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
68071-3064-62021-02-11C16284748780-1ba0f9c33-5850-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
68071-3064-82021-02-11C16284748780-1ba0f9c33-5850-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
68071-3064-92021-02-11C16284748780-1ba0f9c33-5850-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
68071-3064-32021-01-29C16284748780-1ba0f9c33-5850-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
68071-3064-52021-01-29C16284748780-1ba0f9c33-5850-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
68071-3064-62021-01-29C16284748780-1ba0f9c33-5850-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
68071-3064-82021-01-29C16284748780-1ba0f9c33-5850-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
68071-3064-92021-01-29C16284748780-1ba0f9c33-5850-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
68071-3064-2LISINOPRIL120 in 1 BOTTLETABLET1206
68071-3064-3LISINOPRIL30 in 1 BOTTLETABLET306
68071-3064-5LISINOPRIL45 in 1 BOTTLETABLET456
68071-3064-6LISINOPRIL60 in 1 BOTTLETABLET606
68071-3064-8LISINOPRIL180 in 1 BOTTLETABLET1806
68071-3064-9LISINOPRIL90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3064LISINOPRIL TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 6 package rows20240720_6314e49c-8715-2f01-e053-2a91aa0ab2a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSN6314e49c-8715-2f01-e053-2a91aa0ab2a56
197884lisinopril 40 MG Oral TabletSCD6314e49c-8715-2f01-e053-2a91aa0ab2a56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3064-268071306402120 TABLET in 1 BOTTLE (68071-3064-2) 120 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-36807130640330 TABLET in 1 BOTTLE (68071-3064-3) 30 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-56807130640545 TABLET in 1 BOTTLE (68071-3064-5) 45 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-66807130640660 TABLET in 1 BOTTLE (68071-3064-6) 60 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-868071306408180 TABLET in 1 BOTTLE (68071-3064-8) 180 tablet2018-01-180000-00-00NoNoCurrent
68071-3064-96807130640990 TABLET in 1 BOTTLE (68071-3064-9) 90 tablet2018-01-180000-00-00NoNoCurrent