FDA.reportPublic FDA data

lisinopril

Product NDC
76282-421
11-digit product format
762820421
Labeler code
76282
Product ID
76282-421_3e79fbc7-ef6e-4f2f-99a3-7ae3c1e1eec7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA203508
Marketing category
ANDA
Marketing start
2017-03-22
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
Rxcui197884, 205326, 311353, 311354, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-421-01lisinopril100 in 1 BOTTLETABLET1006
76282-421-05lisinopril500 in 1 BOTTLETABLET5006
76282-421-10lisinopril1000 in 1 BOTTLETABLET10006
76282-421-18lisinopril180 in 1 BOTTLETABLET1806
76282-421-30lisinopril30 in 1 BOTTLETABLET306
76282-421-45lisinopril45 in 1 BOTTLETABLET456
76282-421-90lisinopril90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-421LISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 7 package rows20201008_1bc69836-a659-4e3b-84a7-a00b7c4dc268.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
311353lisinopril 2.5 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
314077lisinopril 20 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
205326lisinopril 30 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
197884lisinopril 40 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
311354lisinopril 5 MG Oral TabletPSN1bc69836-a659-4e3b-84a7-a00b7c4dc2686
314076lisinopril 10 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686
311353lisinopril 2.5 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686
314077lisinopril 20 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686
205326lisinopril 30 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686
197884lisinopril 40 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686
311354lisinopril 5 MG Oral TabletSCD1bc69836-a659-4e3b-84a7-a00b7c4dc2686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-421-0176282042101100 TABLET in 1 BOTTLE (76282-421-01) 100 tablet2017-03-220000-00-00NoNoCurrent
76282-421-0576282042105500 TABLET in 1 BOTTLE (76282-421-05) 500 tablet2017-03-220000-00-00NoNoCurrent
76282-421-10762820421101000 TABLET in 1 BOTTLE (76282-421-10) 1000 tablet2017-03-220000-00-00NoNoCurrent
76282-421-1876282042118180 TABLET in 1 BOTTLE (76282-421-18) 180 tablet2017-03-220000-00-00NoNoCurrent
76282-421-307628204213030 TABLET in 1 BOTTLE (76282-421-30) 30 tablet2017-03-220000-00-00NoNoCurrent
76282-421-457628204214545 TABLET in 1 BOTTLE (76282-421-45) 45 tablet2017-03-220000-00-00NoNoCurrent
76282-421-907628204219090 TABLET in 1 BOTTLE (76282-421-90) 90 tablet2017-03-220000-00-00NoNoCurrent