FDA.reportPublic FDA data

Lisinopril

Product NDC
72865-211
11-digit product format
728650211
Labeler code
72865
Product ID
72865-211_c008ecb6-970d-4ac9-9402-e21e8d9d76b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA075903
Marketing category
ANDA
Marketing start
2021-08-17
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
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
72865-211-01Lisinopril100 in 1 BOTTLETABLET1001
72865-211-10Lisinopril1000 in 1 BOTTLETABLET10001
72865-211-18Lisinopril180 in 1 BOTTLETABLET1801
72865-211-45Lisinopril45 in 1 BOTTLETABLET451
72865-211-50Lisinopril5000 in 1 BOTTLETABLET50001
72865-211-90Lisinopril90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-211LISINOPRIL TABLET [XLCARE PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 6 package rows20211023_c008ecb6-970d-4ac9-9402-e21e8d9d76b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
311353lisinopril 2.5 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
314077lisinopril 20 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
205326lisinopril 30 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
197884lisinopril 40 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
311354lisinopril 5 MG Oral TabletPSNc008ecb6-970d-4ac9-9402-e21e8d9d76b21
314076lisinopril 10 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21
311353lisinopril 2.5 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21
314077lisinopril 20 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21
205326lisinopril 30 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21
197884lisinopril 40 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21
311354lisinopril 5 MG Oral TabletSCDc008ecb6-970d-4ac9-9402-e21e8d9d76b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-211-0172865021101100 TABLET in 1 BOTTLE (72865-211-01) 100 tablet2021-08-170000-00-00NoNoCurrent
72865-211-10728650211101000 TABLET in 1 BOTTLE (72865-211-10) 1000 tablet2021-08-170000-00-00NoNoCurrent
72865-211-1872865021118180 TABLET in 1 BOTTLE (72865-211-18) 180 tablet2021-08-170000-00-00NoNoCurrent
72865-211-457286502114545 TABLET in 1 BOTTLE (72865-211-45) 45 tablet2021-08-170000-00-00NoNoCurrent
72865-211-50728650211505000 TABLET in 1 BOTTLE (72865-211-50) 5000 tablet2021-08-170000-00-00NoNoCurrent
72865-211-907286502119090 TABLET in 1 BOTTLE (72865-211-90) 90 tablet2021-08-170000-00-00NoNoCurrent