FDA.reportPublic FDA data

Lisinopril

Product NDC
42708-031
11-digit product format
427080031
Labeler code
42708
Product ID
42708-031_45b3fff5-b53d-af7e-e063-6394a90aeeea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
QPharma Inc
Application
ANDA076059
Marketing category
ANDA
Marketing start
2002-07-01
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
Rxcui197884, 314076, 314077

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
42708-031-302021-03-12C16284748780-1ba0f9c33-262c-a910-e053-dadaa90a0b85These 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
42708-031-302021-01-29C16284748780-1ba0f9c33-262c-a910-e053-dadaa90a0b85These 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
42708-031-30Lisinopril30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-031LISINOPRIL TABLET [QPHARMA INC]5Current NDC, Legacy NDC, 1 package rows20241123_b17cd16b-8d0a-4cfa-bd48-2529983fcd12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314077lisinopril 20 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
197884lisinopril 40 MG Oral TabletPSNb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314076lisinopril 10 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126
314077lisinopril 20 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126
197884lisinopril 40 MG Oral TabletSCDb17cd16b-8d0a-4cfa-bd48-2529983fcd126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-031-304270800313030 TABLET in 1 BOTTLE, PLASTIC (42708-031-30) 30 tablet2018-03-140000-00-00YesNoCurrent