FDA.reportPublic FDA data

Lisinopril

Product NDC
70518-1906
11-digit product format
705181906
Labeler code
70518
Product ID
70518-1906_4988312e-711f-c691-e063-6394a90a6fc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077321
Marketing category
ANDA
Marketing start
2018-10-29
Substance
LISINOPRIL
Active strength
5 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
LISINOPRIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311354

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
70518-1906-0Lisinopril30 in 1 BLISTER PACKTABLET3020
70518-1906-1Lisinopril30 in 1 BLISTER PACKTABLET3020
70518-1906-2Lisinopril90 in 1 BOTTLE, PLASTICTABLET9020
70518-1906-3Lisinopril90 in 1 BOTTLE, PLASTICTABLET9020
70518-1906-4Lisinopril100 in 1 BOTTLE, PLASTICTABLET10020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1906LISINOPRIL TABLET [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 5 package rows20250322_a33d860a-1e17-45b7-aede-51ab3223bebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311354lisinopril 5 MG Oral TabletPSNa33d860a-1e17-45b7-aede-51ab3223bebd20
311354lisinopril 5 MG Oral TabletSCDa33d860a-1e17-45b7-aede-51ab3223bebd20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1906-07051819060030 in 1 BLISTER PACKHistorical
70518-1906-17051819060130 TABLET in 1 BLISTER PACK (70518-1906-1) 30 tablet2020-09-220000-00-00NoNoCurrent
70518-1906-27051819060290 TABLET in 1 BOTTLE, PLASTIC (70518-1906-2) 90 tablet2020-12-130000-00-00NoNoCurrent
70518-1906-37051819060390 TABLET in 1 BOTTLE, PLASTIC (70518-1906-3) 90 tablet2022-02-020000-00-00NoNoCurrent
70518-1906-470518190604100 TABLET in 1 BOTTLE, PLASTIC (70518-1906-4) 100 tablet2025-03-19NoNoCurrent