FDA.reportPublic FDA data

lisinopril

Product NDC
71335-3008
11-digit product format
713353008
Labeler code
71335
Product ID
71335-3008_302b2a97-9731-4739-9131-3e4ddfe3aedf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076102
Marketing category
ANDA
Marketing start
2023-09-06
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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3008-1lisinopril30 in 1 BOTTLETABLET301
71335-3008-2lisinopril90 in 1 BOTTLETABLET901
71335-3008-3lisinopril60 in 1 BOTTLETABLET601
71335-3008-4lisinopril10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSNd8a0c806-8f5e-41c0-91c6-ad267af27a531
311353lisinopril 2.5 MG Oral TabletSCDd8a0c806-8f5e-41c0-91c6-ad267af27a531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3008-17133530080130 TABLET in 1 BOTTLE (71335-3008-1) 30 tablet2026-02-04NoNoHistorical
71335-3008-27133530080290 TABLET in 1 BOTTLE (71335-3008-2) 90 tablet2026-02-04NoNoHistorical
71335-3008-37133530080360 TABLET in 1 BOTTLE (71335-3008-3) 60 tablet2026-02-04NoNoHistorical
71335-3008-47133530080410 TABLET in 1 BOTTLE (71335-3008-4) 10 tablet2026-02-04NoNoHistorical