FDA.reportPublic FDA data

LISINOPRIL

Product NDC
51655-399
11-digit product format
516550399
Labeler code
51655
Product ID
51655-399_48feeaf2-dc8f-e6ae-e063-6294a90afdd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076164
Marketing category
ANDA
Marketing start
2020-04-27
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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-399-522023-03-27C16284748780-1f386c64a-1368-0266-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
51655-399-522023-01-30C16284748780-1f386c64a-1368-0266-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
51655-399-26LISINOPRIL90 in 1 BOTTLE, PLASTICTABLET906
51655-399-52LISINOPRIL30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-399-52EA - Each51655-3996b9f5b3b-a5bd-4bc4-945e-e1336d76935212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-399LISINOPRIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_ae2cdf9b-e71e-8315-e053-2995a90a5310.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314076lisinopril 10 MG Oral TabletPSNae2cdf9b-e71e-8315-e053-2995a90a53106
314076lisinopril 10 MG Oral TabletSCDae2cdf9b-e71e-8315-e053-2995a90a53106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-399-265165503992690 TABLET in 1 BOTTLE, PLASTIC (51655-399-26) 90 tablet2020-11-250000-00-00NoNoCurrent
51655-399-525165503995230 TABLET in 1 BOTTLE, PLASTIC (51655-399-52) 30 tablet2020-04-270000-00-00NoNoCurrent