ENALAPRIL MALEATE

Product NDC
45865-404
11-digit product format
458650404
Labeler code
45865
Product ID
45865-404_715df815-c9c6-0972-e053-2a95a90a0e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA075483
Marketing category
ANDA
Marketing start
2009-12-11
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-404-302025-01-30C16284748780-12cef2736-7012-d83d-e063-dadaa90ab31fENALAPRIL MALEATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-404-30ENALAPRIL MALEATE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-404ENALAPRIL MALEATE TABLET [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 1 package rows20180720_715df815-c9c5-0972-e053-2a95a90a0e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSN715df815-c9c5-0972-e053-2a95a90a0e853
858813enalapril maleate 5 MG Oral TabletSCD715df815-c9c5-0972-e053-2a95a90a0e853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-404-304586504043030 TABLET in 1 BOTTLE (45865-404-30) 30 tablet2018-01-010000-00-00NoNoCurrent