ENALAPRIL MALEATE

Product NDC
61919-277
11-digit product format
619190277
Labeler code
61919
Product ID
61919-277_eac61874-4a12-7c85-e053-2995a90a5935
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA075483
Marketing category
ANDA
Marketing start
2015-12-03
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
10 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
2023-12-31
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
61919-277-302025-01-30C16284748780-12cef2736-b21d-d83d-e063-dadaa90ab31fENALAPRIL MALEATE
61919-277-902025-01-30C16284748780-12cef2736-b21d-d83d-e063-dadaa90ab31fENALAPRIL MALEATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-277-30ENALAPRIL MALEATE30 in 1 BOTTLETABLET304
61919-277-90ENALAPRIL MALEATE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-277-30EA - Each61919-277cafd1686-4367-4883-82a5-2feba97547e312016-02-04
61919-277-90EA - Each61919-2772413999a-23ce-4b4f-af93-40b83ec536e512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-277ENALAPRIL MALEATE TABLET [DIRECTRX]4Legacy NDC, 2 package rows20221012_260054b1-f94c-3e57-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN260054b1-f94c-3e57-e054-00144ff88e884
858817enalapril maleate 10 MG Oral TabletSCD260054b1-f94c-3e57-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-277-306191902773030 TABLET in 1 BOTTLE (61919-277-30) 30 tablet2015-12-030000-00-00NoNoCurrent
61919-277-906191902779090 TABLET in 1 BOTTLE (61919-277-90) 90 tablet2015-12-030000-00-00NoNoCurrent