FDA.reportPublic FDA data

Lisinopril

Product NDC
71335-1380
11-digit product format
713351380
Labeler code
71335
Product ID
71335-1380_6c9b8de6-b09e-4fee-97d1-46fc808a254c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076059
Marketing category
ANDA
Marketing start
2002-07-01
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1380-1Lisinopril30 in 1 BOTTLETABLET302
71335-1380-2Lisinopril90 in 1 BOTTLETABLET902
71335-1380-3Lisinopril60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1380LISINOPRIL TABLET [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 3 package rows20241009_33ebf3f2-cd71-4d8b-ac22-1a20a068a13d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSN33ebf3f2-cd71-4d8b-ac22-1a20a068a13d2
311353lisinopril 2.5 MG Oral TabletSCD33ebf3f2-cd71-4d8b-ac22-1a20a068a13d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1380-17133513800130 TABLET in 1 BOTTLE (71335-1380-1) 30 tablet2019-10-310000-00-00NoNoCurrent
71335-1380-27133513800290 TABLET in 1 BOTTLE (71335-1380-2) 90 tablet2019-10-310000-00-00NoNoCurrent
71335-1380-37133513800360 TABLET in 1 BOTTLE (71335-1380-3) 60 tablet2019-10-310000-00-00NoNoCurrent