FDA.reportPublic FDA data

LISINOPRIL

Product NDC
43063-786
11-digit product format
430630786
Labeler code
43063
Product ID
43063-786_32850517-fae5-3e53-e063-6294a90adf73
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
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
Rxcui314077

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
43063-786-14LISINOPRIL14 in 1 BOTTLE, PLASTICTABLET1420
43063-786-30LISINOPRIL30 in 1 BOTTLE, PLASTICTABLET3020
43063-786-60LISINOPRIL60 in 1 BOTTLE, PLASTICTABLET6020
43063-786-90LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET9020
43063-786-93LISINOPRIL180 in 1 BOTTLE, PLASTICTABLET18020
43063-786-98LISINOPRIL120 in 1 BOTTLE, PLASTICTABLET12020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-786LISINOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 6 package rows20250413_e4c11545-00da-4675-856a-7e600a2f4bd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSNe4c11545-00da-4675-856a-7e600a2f4bd920
314077lisinopril 20 MG Oral TabletSCDe4c11545-00da-4675-856a-7e600a2f4bd920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-786-144306307861414 TABLET in 1 BOTTLE, PLASTIC (43063-786-14) 14 tablet2017-08-310000-00-00NoNoCurrent
43063-786-304306307863030 TABLET in 1 BOTTLE, PLASTIC (43063-786-30) 30 tablet2017-08-310000-00-00NoNoCurrent
43063-786-604306307866060 TABLET in 1 BOTTLE, PLASTIC (43063-786-60) 60 tablet2017-09-200000-00-00NoNoCurrent
43063-786-904306307869090 TABLET in 1 BOTTLE, PLASTIC (43063-786-90) 90 tablet2017-08-310000-00-00NoNoCurrent
43063-786-9343063078693180 TABLET in 1 BOTTLE, PLASTIC (43063-786-93) 180 tablet2017-09-280000-00-00NoNoCurrent
43063-786-9843063078698120 TABLET in 1 BOTTLE, PLASTIC (43063-786-98) 120 tablet2017-10-030000-00-00NoNoCurrent