FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43063-769
11-digit product format
430630769
Labeler code
43063
Product ID
43063-769_32849fdc-834d-d2c8-e063-6294a90a25ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076164
Marketing category
ANDA
Marketing start
2011-11-01
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
Rxcui314076

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
43063-769-01LISINOPRIL100 in 1 BOTTLE, PLASTICTABLET10014
43063-769-12LISINOPRIL12 in 1 BOTTLE, PLASTICTABLET1214
43063-769-14LISINOPRIL14 in 1 BOTTLE, PLASTICTABLET1414
43063-769-30LISINOPRIL30 in 1 BOTTLE, PLASTICTABLET3014
43063-769-60LISINOPRIL60 in 1 BOTTLE, PLASTICTABLET6014
43063-769-90LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET9014
43063-769-93LISINOPRIL180 in 1 BOTTLE, PLASTICTABLET18014
43063-769-98LISINOPRIL120 in 1 BOTTLE, PLASTICTABLET12014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-769-01EA - Each43063-76973c6fe15-c090-4b02-9a8a-074661be65a112020-05-08
43063-769-12EA - Each43063-769bb6edd9c-8765-4c23-92e2-c46af0739d3812017-11-06
43063-769-14EA - Each43063-769d3a8d608-b36f-4650-a523-bf000c25de4b12020-05-08
43063-769-30EA - Each43063-76915e60041-0ab4-48cb-969d-a6f4ff7a353c12017-07-07
43063-769-60EA - Each43063-769df11e719-b05f-495e-a71e-b24f71baa66812017-07-07
43063-769-90EA - Each43063-7694cdc87be-100f-43d9-a6b1-32086b4e7f1112017-07-07
43063-769-93EA - Each43063-7699fa3ef8e-9291-4d5e-af6f-b715e0eef31912017-07-07
43063-769-98EA - Each43063-769134114fd-c9d0-4e36-80ae-92b2f46e13ee12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-769LISINOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 8 package rows20250413_03a497fe-fb09-4b2c-8ee0-2019600192b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN03a497fe-fb09-4b2c-8ee0-2019600192b814
314076lisinopril 10 MG Oral TabletSCD03a497fe-fb09-4b2c-8ee0-2019600192b814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-769-0143063076901100 TABLET in 1 BOTTLE, PLASTIC (43063-769-01) 100 tablet2017-05-230000-00-00NoNoCurrent
43063-769-124306307691212 TABLET in 1 BOTTLE, PLASTIC (43063-769-12) 12 tablet2017-05-230000-00-00NoNoCurrent
43063-769-144306307691414 TABLET in 1 BOTTLE, PLASTIC (43063-769-14) 14 tablet2017-05-230000-00-00NoNoCurrent
43063-769-304306307693030 TABLET in 1 BOTTLE, PLASTIC (43063-769-30) 30 tablet2017-05-230000-00-00NoNoCurrent
43063-769-604306307696060 TABLET in 1 BOTTLE, PLASTIC (43063-769-60) 60 tablet2017-05-230000-00-00NoNoCurrent
43063-769-904306307699090 TABLET in 1 BOTTLE, PLASTIC (43063-769-90) 90 tablet2017-05-230000-00-00NoNoCurrent
43063-769-9343063076993180 TABLET in 1 BOTTLE, PLASTIC (43063-769-93) 180 tablet2017-05-230000-00-00NoNoCurrent
43063-769-9843063076998120 TABLET in 1 BOTTLE, PLASTIC (43063-769-98) 120 tablet2017-05-230000-00-00NoNoCurrent