FDA.reportPublic FDA data

Lisinopril

Product NDC
70518-2561
11-digit product format
705182561
Labeler code
70518
Product ID
70518-2561_4a67cd3d-dd9f-0fc4-e063-6294a90a1664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2020-02-01
Substance
LISINOPRIL
Active strength
30 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lisinopril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LISINOPRIL30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui205326

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
70518-2561-0Lisinopril30 in 1 BLISTER PACKTABLET3014
70518-2561-1Lisinopril90 in 1 BOTTLE, PLASTICTABLET9014
70518-2561-2Lisinopril100 in 1 BOTTLE, PLASTICTABLET10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2561LISINOPRIL TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250326_a35079fa-b693-45e8-9715-488e33e7c1a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205326lisinopril 30 MG Oral TabletPSNa35079fa-b693-45e8-9715-488e33e7c1a914
205326lisinopril 30 MG Oral TabletSCDa35079fa-b693-45e8-9715-488e33e7c1a914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2561-07051825610030 TABLET in 1 BLISTER PACK (70518-2561-0) 30 tablet2020-02-010000-00-00NoNoCurrent
70518-2561-17051825610190 TABLET in 1 BOTTLE, PLASTIC (70518-2561-1) 90 tablet2020-03-250000-00-00NoNoCurrent
70518-2561-270518256102100 TABLET in 1 BOTTLE, PLASTIC (70518-2561-2) 100 tablet2025-03-21NoNoHistorical