FDA.reportPublic FDA data

Lisinopril

Product NDC
68071-3411
11-digit product format
680713411
Labeler code
68071
Product ID
68071-3411_2d6c6bd0-3324-06df-e063-6394a90af2df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2017-05-12
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
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
LISINOPRIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui314076

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
68071-3411-22025-02-04C16284748780-12cef2736-8d96-d83d-e063-dadaa90ab31fThese 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
68071-3411-92025-02-04C16284748780-12cef2736-8d96-d83d-e063-dadaa90ab31fThese 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
68071-3411-22025-01-30C16284748780-12cef2736-8d96-d83d-e063-dadaa90ab31fThese 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
68071-3411-92025-01-30C16284748780-12cef2736-8d96-d83d-e063-dadaa90ab31fThese 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
68071-3411-2Lisinopril120 in 1 BOTTLETABLET1204
68071-3411-9Lisinopril90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3411LISINOPRIL TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 2 package rows20250207_fbfa23c2-dae0-4f45-e053-6394a90a4fef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNfbfa23c2-dae0-4f45-e053-6394a90a4fef4
314076lisinopril 10 MG Oral TabletSCDfbfa23c2-dae0-4f45-e053-6394a90a4fef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3411-268071341102120 TABLET in 1 BOTTLE (68071-3411-2) 120 tablet2023-05-18NoNoHistorical
68071-3411-96807134110990 TABLET in 1 BOTTLE (68071-3411-9) 90 tablet2023-05-18NoNoHistorical