FDA.reportPublic FDA data

LISINOPRIL

Product NDC
76282-729
11-digit product format
762820729
Labeler code
76282
Product ID
76282-729_c3c02066-1571-4291-ae9a-fd50a43486ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LISINOPRIL
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc
Application
ANDA076102
Marketing category
ANDA
Marketing start
2023-04-07
Substance
LISINOPRIL
Active strength
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
LISINOPRIL5 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
76282-729-01LISINOPRIL100 in 1 BOTTLETABLET1008
76282-729-05LISINOPRIL500 in 1 BOTTLETABLET5008
76282-729-10LISINOPRIL1000 in 1 BOTTLETABLET10008
76282-729-18LISINOPRIL180 in 1 BOTTLETABLET1808
76282-729-30LISINOPRIL30 in 1 BOTTLETABLET308
76282-729-45LISINOPRIL45 in 1 BOTTLETABLET458
76282-729-90LISINOPRIL90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-729-01EA - Each76282-7297a89ebcf-fc8c-4de5-81f6-a9fd4b2b490012023-07-06
76282-729-10EA - Each76282-729f436c059-2b10-486c-acd3-6dea02035ee112023-07-06
76282-729-45EA - Each76282-72926950f1b-66e3-4e72-b74a-27ace7e36cff12023-07-06
76282-729-90EA - Each76282-729d6117d9d-1eba-4fea-87db-b9b3db54519412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-729LISINOPRIL TABLET [EXELAN PHARMACEUTICALS, INC]8Current NDC, 7 package rows20240504_4aad4d30-3e18-489c-80ad-ccf7532bb933.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
311353lisinopril 2.5 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
314077lisinopril 20 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
205326lisinopril 30 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
197884lisinopril 40 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
311354lisinopril 5 MG Oral TabletPSN4aad4d30-3e18-489c-80ad-ccf7532bb9338
314076lisinopril 10 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
311353lisinopril 2.5 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
314077lisinopril 20 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
205326lisinopril 30 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
197884lisinopril 40 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
311354lisinopril 5 MG Oral TabletSCD4aad4d30-3e18-489c-80ad-ccf7532bb9338
311354lisinopril 5 MG Oral TabletPSNaeee8e9a-333a-416e-ab69-a0d40e1468831
311354lisinopril 5 MG Oral TabletSCDaeee8e9a-333a-416e-ab69-a0d40e1468831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-729-0176282072901100 TABLET in 1 BOTTLE (76282-729-01) 100 tablet2023-04-07NoNoCurrent
76282-729-0576282072905500 TABLET in 1 BOTTLE (76282-729-05) 500 tablet2023-04-07NoNoCurrent
76282-729-10762820729101000 TABLET in 1 BOTTLE (76282-729-10) 1000 tablet2023-04-07NoNoCurrent
76282-729-1876282072918180 TABLET in 1 BOTTLE (76282-729-18) 180 tablet2023-04-07NoNoCurrent
76282-729-307628207293030 TABLET in 1 BOTTLE (76282-729-30) 30 tablet2023-04-07NoNoCurrent
76282-729-457628207294545 TABLET in 1 BOTTLE (76282-729-45) 45 tablet2023-04-07NoNoCurrent
76282-729-907628207299090 TABLET in 1 BOTTLE (76282-729-90) 90 tablet2023-04-07NoNoCurrent