FDA.reportPublic FDA data

LISINOPRIL

Product NDC
71335-0354
11-digit product format
713350354
Labeler code
71335
Product ID
71335-0354_bebf037f-10f8-4e1f-a512-614f81deb891
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LISINOPRIL
Active strength
30 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
LISINOPRIL30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui205326

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
71335-0354-1LISINOPRIL30 in 1 BOTTLETABLET30102
71335-0354-2LISINOPRIL60 in 1 BOTTLETABLET60102
71335-0354-3LISINOPRIL90 in 1 BOTTLETABLET90102
71335-0354-4LISINOPRIL120 in 1 BOTTLETABLET120102
71335-0354-5LISINOPRIL10 in 1 BOTTLETABLET10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0354LISINOPRIL TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20241025_bebf037f-10f8-4e1f-a512-614f81deb891.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205326lisinopril 30 MG Oral TabletPSNbebf037f-10f8-4e1f-a512-614f81deb891102
205326lisinopril 30 MG Oral TabletSCDbebf037f-10f8-4e1f-a512-614f81deb891102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0354-17133503540130 TABLET in 1 BOTTLE (71335-0354-1) 30 tablet2018-07-100000-00-00NoNoCurrent
71335-0354-27133503540260 TABLET in 1 BOTTLE (71335-0354-2) 60 tablet2019-09-170000-00-00NoNoCurrent
71335-0354-37133503540390 TABLET in 1 BOTTLE (71335-0354-3) 90 tablet2018-08-210000-00-00NoNoCurrent
71335-0354-471335035404120 TABLET in 1 BOTTLE (71335-0354-4) 120 tablet2024-10-080000-00-00NoNoCurrent
71335-0354-57133503540510 TABLET in 1 BOTTLE (71335-0354-5) 10 tablet2024-10-080000-00-00NoNoCurrent