FDA.reportPublic FDA data

lisinopril

Product NDC
76282-422
11-digit product format
762820422
Labeler code
76282
Product ID
76282-422_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
40 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

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
76282-422-01lisinopril100 in 1 BOTTLETABLET1006
76282-422-05lisinopril500 in 1 BOTTLETABLET5006
76282-422-10lisinopril1000 in 1 BOTTLETABLET10006
76282-422-18lisinopril180 in 1 BOTTLETABLET1806
76282-422-30lisinopril30 in 1 BOTTLETABLET306
76282-422-45lisinopril45 in 1 BOTTLETABLET456
76282-422-90lisinopril90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-422-01EA - Each76282-42212597caf-2ab9-4809-a745-089a6927935912017-03-06
76282-422-05EA - Each76282-422022d2498-4490-4441-a1a5-5f38aa9556bc12014-05-02
76282-422-10EA - Each76282-42216718ff1-6918-454a-a25d-fdfbd007342812014-05-02
76282-422-18EA - Each76282-422add1a2c8-83aa-4970-894a-9427d297c6c612014-05-02
76282-422-45EA - Each76282-422f23813fb-c72f-4e54-ac51-aca75d72852012014-05-02
76282-422-90EA - Each76282-422ef87b08e-49e2-414c-a8e0-581fbeafcdf512014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [EXELAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-422LISINOPRIL 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
314076lisinopril 10 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
311353lisinopril 2.5 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
314077lisinopril 20 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
197884lisinopril 40 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
311354lisinopril 5 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
314076lisinopril 10 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
311353lisinopril 2.5 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
314077lisinopril 20 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
197884lisinopril 40 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
311354lisinopril 5 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-422-0176282042201100 TABLET in 1 BOTTLE (76282-422-01) 100 tablet2017-03-220000-00-00NoNoCurrent
76282-422-0576282042205500 TABLET in 1 BOTTLE (76282-422-05) 500 tablet2017-03-220000-00-00NoNoCurrent
76282-422-10762820422101000 TABLET in 1 BOTTLE (76282-422-10) 1000 tablet2017-03-220000-00-00NoNoCurrent
76282-422-1876282042218180 TABLET in 1 BOTTLE (76282-422-18) 180 tablet2017-03-220000-00-00NoNoCurrent
76282-422-307628204223030 TABLET in 1 BOTTLE (76282-422-30) 30 tablet2017-03-220000-00-00NoNoCurrent
76282-422-457628204224545 TABLET in 1 BOTTLE (76282-422-45) 45 tablet2017-03-220000-00-00NoNoCurrent
76282-422-907628204229090 TABLET in 1 BOTTLE (76282-422-90) 90 tablet2017-03-220000-00-00NoNoCurrent