FDA.reportPublic FDA data

Lisinopril

Product NDC
72789-093
11-digit product format
727890093
Labeler code
72789
Product ID
72789-093_3ca56f64-b651-2dca-e063-6294a90aec70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2017-05-12
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
72789-093-30Lisinopril30 in 1 BOTTLE, PLASTICTABLET3023
72789-093-90Lisinopril90 in 1 BOTTLE, PLASTICTABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-093-30EA - Each72789-093624ed3f5-d2b3-4766-bd16-c30dd7a74f8d12020-08-06
72789-093-90EA - Each72789-093916b936f-e25d-445a-bebb-a923e5acfe3b12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-093LISINOPRIL TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 2 package rows20240719_9470b102-3c81-469a-a4c5-6816d9d39b07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSN9470b102-3c81-469a-a4c5-6816d9d39b0723
314077lisinopril 20 MG Oral TabletSCD9470b102-3c81-469a-a4c5-6816d9d39b0723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-093-307278900933030 TABLET in 1 BOTTLE, PLASTIC (72789-093-30) 30 tablet2020-06-230000-00-00NoNoCurrent
72789-093-907278900939090 TABLET in 1 BOTTLE, PLASTIC (72789-093-90) 90 tablet2020-06-190000-00-00NoNoCurrent