FDA.reportPublic FDA data

Lisinopril

Product NDC
0615-8405
11-digit product format
006158405
Labeler code
0615
Product ID
0615-8405_25cc7469-c2d8-4d68-9286-f4ee8f1ae90f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077321
Marketing category
ANDA
Marketing start
2021-06-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884, 205326

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8405-05Lisinopril15 in 1 BLISTER PACKTABLET1518
0615-8405-39Lisinopril30 in 1 BLISTER PACKTABLET3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8405LISINOPRIL TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]18Current NDC, Legacy NDC, 2 package rows20241020_3121a4c6-d5c2-4608-a0be-2d9f4b955d5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205326lisinopril 30 MG Oral TabletPSN3121a4c6-d5c2-4608-a0be-2d9f4b955d5f18
197884lisinopril 40 MG Oral TabletPSN3121a4c6-d5c2-4608-a0be-2d9f4b955d5f18
205326lisinopril 30 MG Oral TabletSCD3121a4c6-d5c2-4608-a0be-2d9f4b955d5f18
197884lisinopril 40 MG Oral TabletSCD3121a4c6-d5c2-4608-a0be-2d9f4b955d5f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8405-050061584050515 TABLET in 1 BLISTER PACK (0615-8405-05) 15 tablet2021-09-020000-00-00NoNoCurrent
0615-8405-390061584053930 TABLET in 1 BLISTER PACK (0615-8405-39) 30 tablet2021-09-020000-00-00NoNoCurrent