FDA.reportPublic FDA data

LISINOPRIL

Product NDC
51655-411
11-digit product format
516550411
Labeler code
51655
Product ID
51655-411_494def40-12cd-a402-e063-6394a90a88e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076164
Marketing category
ANDA
Marketing start
2020-03-13
Substance
LISINOPRIL
Active strength
20 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
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR
Rxcui314077

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
51655-411-262023-03-27C16284748780-1f386c64a-471c-0266-e053-dadaa90a7c1aThese 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
51655-411-522023-03-27C16284748780-1f386c64a-471c-0266-e053-dadaa90a7c1aThese 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
51655-411-262023-01-30C16284748780-1f386c64a-471c-0266-e053-dadaa90a7c1aThese 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
51655-411-522023-01-30C16284748780-1f386c64a-471c-0266-e053-dadaa90a7c1aThese 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
51655-411-26LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET905
51655-411-52LISINOPRIL30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-411-52EA - Each51655-4115e4cccb6-3419-4aee-8734-6b4911dff40512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-411LISINOPRIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241220_ae2d9df4-29ce-3d07-e053-2995a90ab184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314077lisinopril 20 MG Oral TabletPSNae2d9df4-29ce-3d07-e053-2995a90ab1845
314077lisinopril 20 MG Oral TabletSCDae2d9df4-29ce-3d07-e053-2995a90ab1845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-411-265165504112690 TABLET in 1 BOTTLE, PLASTIC (51655-411-26) 90 tablet2020-06-030000-00-00NoNoCurrent
51655-411-525165504115230 TABLET in 1 BOTTLE, PLASTIC (51655-411-52) 30 tablet2020-03-130000-00-00NoNoCurrent