FDA.reportPublic FDA data

Lisinopril

Product NDC
70518-1152
11-digit product format
705181152
Labeler code
70518
Product ID
70518-1152_51009ede-acb0-bf22-e063-6394a90a9a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2018-05-01
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
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
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
70518-1152-0Lisinopril30 in 1 BLISTER PACKTABLET3022
70518-1152-1Lisinopril28 in 1 BLISTER PACKTABLET2822
70518-1152-2Lisinopril90 in 1 BOTTLE, PLASTICTABLET9022
70518-1152-3Lisinopril30 in 1 BOTTLE, PLASTICTABLET3022
70518-1152-4Lisinopril30 in 1 BOTTLE, PLASTICTABLET3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1152LISINOPRIL TABLET [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 5 package rows20250507_34bb4602-ccff-4939-91b9-26a63bfd40f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSN34bb4602-ccff-4939-91b9-26a63bfd40f722
314076lisinopril 10 MG Oral TabletSCD34bb4602-ccff-4939-91b9-26a63bfd40f722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1152-07051811520030 TABLET in 1 BLISTER PACK (70518-1152-0) 30 tablet2018-05-010000-00-00NoNoCurrent
70518-1152-17051811520128 in 1 BLISTER PACKHistorical
70518-1152-27051811520290 in 1 BOTTLE, PLASTICHistorical
70518-1152-37051811520330 in 1 BOTTLE, PLASTICHistorical
70518-1152-47051811520430 in 1 BOTTLE, PLASTICHistorical