FDA.reportPublic FDA data

NDC 53002-3225 - Lisinopril

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53002-3225
Package NDCs from labels
53002-3225-0, 53002-3225-3, 53002-3225-6
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2023-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lisinopril - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-09-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-3225-02025-01-30C16284748780-12cef2736-9478-d83d-e063-dadaa90ab31fThese 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
53002-3225-32025-01-30C16284748780-12cef2736-9478-d83d-e063-dadaa90ab31fThese 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
53002-3225-62025-01-30C16284748780-12cef2736-9478-d83d-e063-dadaa90ab31fThese 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
53002-3225-0Lisinopril100 in 1 BOTTLETABLET1002
53002-3225-3Lisinopril30 in 1 BOTTLETABLET302
53002-3225-6Lisinopril60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3225LISINOPRIL TABLET [RPK PHARMACEUTICALS, INC.]23 package rows20230912_1e782cd9-bcfa-4be8-84ad-069d99af5f1c.zip