FDA.reportPublic FDA data

LISINOPRIL

Product NDC
70518-1790
11-digit product format
705181790
Labeler code
70518
Product ID
70518-1790_4975662c-d457-ab02-e063-6294a90af2cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076180
Marketing category
ANDA
Marketing start
2019-01-11
Substance
LISINOPRIL
Active strength
2.5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311353

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
70518-1790-12023-03-06C16284748780-1f386c64a-0d3d-0266-e053-dadaa90a7c1aThese 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
70518-1790-12023-01-30C16284748780-1f386c64a-0d3d-0266-e053-dadaa90a7c1aThese 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
70518-1790-0LISINOPRIL1 in 1 POUCHTABLET19
70518-1790-1LISINOPRIL100 in 1 BOXTABLET1009
70518-1790-2LISINOPRIL100 in 1 BOTTLE, PLASTICTABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1790LISINOPRIL TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 3 package rows20250424_42f49299-7ae5-4d30-86eb-66b739c0e95d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN42f49299-7ae5-4d30-86eb-66b739c0e95d9
311353lisinopril 2.5 MG Oral TabletSCD42f49299-7ae5-4d30-86eb-66b739c0e95d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1790-0705181790001 in 1 POUCHHistorical
70518-1790-170518179001100 POUCH in 1 BOX (70518-1790-1) > 1 TABLET in 1 POUCH (70518-1790-0) 100 pouch2021-03-190000-00-00NoNoCurrent
70518-1790-270518179002100 TABLET in 1 BOTTLE, PLASTIC (70518-1790-2) 100 tablet2025-04-22NoNoHistorical