lisinopril

Product NDC
43353-301
11-digit product format
433530301
Labeler code
43353
Product ID
43353-301_c7e48d97-db9a-465d-938b-215db53d3f58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203508
Marketing category
ANDA
Marketing start
2014-03-15
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, 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
43353-301-30lisinopril30 in 1 BOTTLETABLET304
43353-301-45lisinopril45 in 1 BOTTLETABLET454
43353-301-60lisinopril90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-301-30EA - Each43353-301b228cd14-f941-4149-bde5-0b96ac0bd47f12017-07-07
43353-301-45EA - Each43353-301832f2cb7-3f5d-47bf-844c-0704f9722bae12021-04-08
43353-301-60EA - Each43353-30193a864f1-91b3-4847-8c5a-888afe0ce11112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-301LISINOPRIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 3 package rows20210811_32eb18bc-a80d-4de1-8f38-e591d8f66870.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
311353lisinopril 2.5 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
314077lisinopril 20 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
197884lisinopril 40 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
311354lisinopril 5 MG Oral TabletPSN32eb18bc-a80d-4de1-8f38-e591d8f668704
314076lisinopril 10 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
311353lisinopril 2.5 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
314077lisinopril 20 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
197884lisinopril 40 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704
311354lisinopril 5 MG Oral TabletSCD32eb18bc-a80d-4de1-8f38-e591d8f668704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-301-304335303013030 TABLET in 1 BOTTLE (43353-301-30) 30 tablet2017-04-040000-00-00NoNoCurrent
43353-301-454335303014545 TABLET in 1 BOTTLE (43353-301-45) 45 tablet2021-03-090000-00-00NoNoCurrent
43353-301-604335303016090 TABLET in 1 BOTTLE (43353-301-60) 90 tablet2021-02-120000-00-00NoNoCurrent