Lisinopril

Product NDC
43547-416
11-digit product format
435470416
Labeler code
43547
Product ID
43547-416_1ed80b02-cb3b-41c5-ab33-ff0106b8792d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Solco healthcare U.S., LLC
Application
ANDA075743
Marketing category
ANDA
Marketing start
2017-08-30
Substance
LISINOPRIL
Active strength
10 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
LISINOPRIL10 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
43547-416-04Lisinopril45 in 1 BOTTLETABLET455
43547-416-09Lisinopril90 in 1 BOTTLETABLET905
43547-416-10Lisinopril100 in 1 BOTTLETABLET1005
43547-416-11Lisinopril1000 in 1 BOTTLETABLET10005
43547-416-15Lisinopril5000 in 1 BOTTLETABLET50005
43547-416-50Lisinopril500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-416-10EA - Each43547-416ec21df46-39b3-4745-85d5-a26a4c5d669812017-11-06
43547-416-11EA - Each43547-4168cb824f9-0bee-4254-88cb-01ec1363187312017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-416LISINOPRIL TABLET [SOLCO HEALTHCARE U.S., LLC]5Current NDC, Legacy NDC, 6 package rows20221118_f8d16c85-50e2-4d99-afae-6fb902734e42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
311353lisinopril 2.5 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
314077lisinopril 20 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
205326lisinopril 30 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
197884lisinopril 40 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
311354lisinopril 5 MG Oral TabletPSNb62815f3-77fc-4074-a28a-918ab5cc32db25
314076lisinopril 10 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
311353lisinopril 2.5 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
314077lisinopril 20 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
205326lisinopril 30 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
197884lisinopril 40 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
311354lisinopril 5 MG Oral TabletSCDb62815f3-77fc-4074-a28a-918ab5cc32db25
314076lisinopril 10 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
311353lisinopril 2.5 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
314077lisinopril 20 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
205326lisinopril 30 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
197884lisinopril 40 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
311354lisinopril 5 MG Oral TabletPSNf8d16c85-50e2-4d99-afae-6fb902734e425
314076lisinopril 10 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425
311353lisinopril 2.5 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425
314077lisinopril 20 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425
205326lisinopril 30 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425
197884lisinopril 40 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425
311354lisinopril 5 MG Oral TabletSCDf8d16c85-50e2-4d99-afae-6fb902734e425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-416-044354704160445 TABLET in 1 BOTTLE (43547-416-04) 45 tablet2017-08-300000-00-00NoNoCurrent
43547-416-094354704160990 TABLET in 1 BOTTLE (43547-416-09) 90 tablet2017-08-300000-00-00NoNoCurrent
43547-416-1043547041610100 TABLET in 1 BOTTLE (43547-416-10) 100 tablet2017-08-300000-00-00NoNoCurrent
43547-416-11435470416111000 TABLET in 1 BOTTLE (43547-416-11) 1000 tablet2017-08-300000-00-00NoNoCurrent
43547-416-15435470416155000 TABLET in 1 BOTTLE (43547-416-15) 5000 tablet2017-08-300000-00-00NoNoCurrent
43547-416-5043547041650500 TABLET in 1 BOTTLE (43547-416-50) 500 tablet2017-08-300000-00-00NoNoCurrent