FDA.reportPublic FDA data

LISINOPRIL

Product NDC
63187-775
11-digit product format
631870775
Labeler code
63187
Product ID
63187-775_b2961dbf-a83c-4c4b-a3bf-5c9e3158f12c
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
20 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
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui314077

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
63187-775-00LISINOPRIL100 in 1 BOTTLETABLET1006
63187-775-30LISINOPRIL30 in 1 BOTTLETABLET306
63187-775-60LISINOPRIL60 in 1 BOTTLETABLET606
63187-775-90LISINOPRIL90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-775-00EA - Each63187-7752abec312-bb24-4840-bc9b-881b3f075ecf12018-06-11
63187-775-30EA - Each63187-77514f8fee4-6ede-43cc-b92e-291421945b2b12017-03-06
63187-775-60EA - Each63187-775aa768369-ab1a-4b87-b572-54322321f28c12018-10-11
63187-775-90EA - Each63187-7755a806da5-a06e-4883-91fd-43663eeebb4012017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-775LISINOPRIL TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220420_06862c94-103d-4b12-8a74-abf52cb42389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSN06862c94-103d-4b12-8a74-abf52cb423896
314077lisinopril 20 MG Oral TabletSCD06862c94-103d-4b12-8a74-abf52cb423896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-775-0063187077500100 TABLET in 1 BOTTLE (63187-775-00) 100 tablet2018-03-010000-00-00NoNoCurrent
63187-775-306318707753030 TABLET in 1 BOTTLE (63187-775-30) 30 tablet2016-11-010000-00-00NoNoCurrent
63187-775-606318707756060 TABLET in 1 BOTTLE (63187-775-60) 60 tablet2016-11-010000-00-00NoNoCurrent
63187-775-906318707759090 TABLET in 1 BOTTLE (63187-775-90) 90 tablet2016-11-010000-00-00NoNoCurrent