FDA.reportPublic FDA data

LISINOPRIL

Product NDC
50090-3765
11-digit product format
500903765
Labeler code
50090
Product ID
50090-3765_52567d48-a07a-4e44-a13f-8655538fff9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LISINOPRIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311354

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
50090-3765-0LISINOPRIL30 in 1 BOTTLETABLET3020
50090-3765-1LISINOPRIL100 in 1 BOTTLETABLET10020
50090-3765-2LISINOPRIL1000 in 1 BOTTLETABLET100020
50090-3765-3LISINOPRIL90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3765-0EA - Each50090-3765576a3b2e-3686-432c-9c98-836ceaca478512021-10-08
50090-3765-3EA - Each50090-3765aa8b09a6-274b-4ef4-9496-61377b058f4812021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3765LISINOPRIL TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 4 package rows20231215_f57bd658-05d8-475a-ae74-87d2c7866417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSNf57bd658-05d8-475a-ae74-87d2c786641720
311354lisinopril 5 MG Oral TabletSCDf57bd658-05d8-475a-ae74-87d2c786641720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3765-05009037650030 TABLET in 1 BOTTLE (50090-3765-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-3765-150090376501100 TABLET in 1 BOTTLE (50090-3765-1) 100 tablet2019-10-100000-00-00NoNoCurrent
50090-3765-2500903765021000 TABLET in 1 BOTTLE (50090-3765-2) 1000 tablet2019-10-100000-00-00NoNoCurrent
50090-3765-35009037650390 TABLET in 1 BOTTLE (50090-3765-3) 90 tablet2018-11-010000-00-00NoNoCurrent