ENALAPRIL MALEATE

Product NDC
63304-522
11-digit product format
633040522
Labeler code
63304
Product ID
63304-522_c9c61aa4-3278-4366-b292-e9a7e321fc8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA075556
Marketing category
ANDA
Marketing start
2016-09-17
Marketing end
0000-00-00
Substance
ENALAPRIL MALEATE
Active strength
3 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
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
63304-522-012020-01-31C16284748780-19d75b9d0-4b64-f424-e053-dadaa90a57ceENALAPRIL MALEATE TABLETS USP
63304-522-102020-01-31C16284748780-19d75b9d0-4b64-f424-e053-dadaa90a57ceENALAPRIL MALEATE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-522-01ENALAPRIL MALEATE100 in 1 BOTTLETABLET1002
63304-522-10ENALAPRIL MALEATE1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-522ENALAPRIL MALEATE TABLET [RANBAXY PHARMACEUTICALS INC.]2Legacy NDC, 2 package rows20160917_a62de3e5-3508-4d4a-9518-65b8fb23b3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858804enalapril maleate 2.5 MG Oral TabletPSNa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858810enalapril maleate 20 MG Oral TabletPSNa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858813enalapril maleate 5 MG Oral TabletPSNa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858817enalapril maleate 10 MG Oral TabletSCDa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858804enalapril maleate 2.5 MG Oral TabletSCDa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858810enalapril maleate 20 MG Oral TabletSCDa62de3e5-3508-4d4a-9518-65b8fb23b3be2
858813enalapril maleate 5 MG Oral TabletSCDa62de3e5-3508-4d4a-9518-65b8fb23b3be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-522-0163304052201100 in 1 BOTTLEHistorical
63304-522-10633040522101000 in 1 BOTTLEHistorical