FDA.reportPublic FDA data

LISINOPRIL

Product NDC
63187-825
11-digit product format
631870825
Labeler code
63187
Product ID
63187-825_17ff0808-5d64-412e-9e99-8a401dfc5aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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

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
63187-825-30LISINOPRIL30 in 1 BOTTLETABLET305
63187-825-60LISINOPRIL60 in 1 BOTTLETABLET605
63187-825-90LISINOPRIL90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-825-30EA - Each63187-825979abbc2-96c2-4a13-ba25-9eda2239ce1f12017-05-04
63187-825-90EA - Each63187-82547f1cd11-e1a0-43a6-8510-288d0277b49612017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-825LISINOPRIL TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220426_3e4e69f6-b8a6-462d-a7ec-4cd6636512d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSN3e4e69f6-b8a6-462d-a7ec-4cd6636512d05
197884lisinopril 40 MG Oral TabletSCD3e4e69f6-b8a6-462d-a7ec-4cd6636512d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-825-306318708253030 TABLET in 1 BOTTLE (63187-825-30) 30 tablet2017-03-010000-00-00NoNoCurrent
63187-825-606318708256060 TABLET in 1 BOTTLE (63187-825-60) 60 tablet2017-03-010000-00-00NoNoCurrent
63187-825-906318708259090 TABLET in 1 BOTTLE (63187-825-90) 90 tablet2017-03-010000-00-00NoNoCurrent