FDA.reportPublic FDA data

Lisinopril

Product NDC
51655-999
11-digit product format
516550999
Labeler code
51655
Product ID
51655-999_4a93aaa5-19f1-d6a1-e063-6294a90a00c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077321
Marketing category
ANDA
Marketing start
2023-02-27
Substance
LISINOPRIL
Active strength
2.5 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
LISINOPRIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui311353

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-999-262026-01-29C16284748780-149896155-c5ea-586f-e063-e6dba90add90These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
51655-999-522026-01-29C16284748780-149896155-c5ea-586f-e063-e6dba90add90These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-999-26Lisinopril90 in 1 BOTTLE, PLASTICTABLET903
51655-999-52Lisinopril30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-999LISINOPRIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230621_f7f78491-bb4f-7ae7-e053-6394a90aff6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311353lisinopril 2.5 MG Oral TabletPSNf7f78491-bb4f-7ae7-e053-6394a90aff6f3
311353lisinopril 2.5 MG Oral TabletSCDf7f78491-bb4f-7ae7-e053-6394a90aff6f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-999-265165509992690 TABLET in 1 BOTTLE, PLASTIC (51655-999-26) 90 tablet2023-02-27NoNoHistorical
51655-999-525165509995230 TABLET in 1 BOTTLE, PLASTIC (51655-999-52) 30 tablet2023-06-13NoNoHistorical