FDA.reportPublic FDA data

Lisinopril

Product NDC
70518-3166
11-digit product format
705183166
Labeler code
70518
Product ID
70518-3166_4ecae466-b400-4f7e-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2021-07-20
Substance
LISINOPRIL
Active strength
40 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
LISINOPRIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui197884

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
70518-3166-0Lisinopril30 in 1 BLISTER PACKTABLET3012
70518-3166-1Lisinopril90 in 1 BOTTLE, PLASTICTABLET9012
70518-3166-2Lisinopril30 in 1 BLISTER PACKTABLET3012
70518-3166-3Lisinopril100 in 1 BOTTLE, PLASTICTABLET10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3166LISINOPRIL TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250322_463308ef-16cb-41d8-8d29-6aae2c5a7b0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197884lisinopril 40 MG Oral TabletPSN463308ef-16cb-41d8-8d29-6aae2c5a7b0f12
197884lisinopril 40 MG Oral TabletSCD463308ef-16cb-41d8-8d29-6aae2c5a7b0f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3166-07051831660030 TABLET in 1 BLISTER PACK (70518-3166-0) 30 tablet2021-07-200000-00-00NoNoCurrent
70518-3166-17051831660190 TABLET in 1 BOTTLE, PLASTIC (70518-3166-1) 90 tablet2021-10-180000-00-00NoNoCurrent
70518-3166-27051831660230 TABLET in 1 BLISTER PACK (70518-3166-2) 30 tablet2021-12-140000-00-00NoNoCurrent
70518-3166-370518316603100 TABLET in 1 BOTTLE, PLASTIC (70518-3166-3) 100 tablet2025-03-19NoNoCurrent