Enalapril Maleate

Product NDC
53808-1108
11-digit product format
538081108
Labeler code
53808
Product ID
53808-1108_5aa27e45-f7a4-471d-869e-be2eb166e07e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA075657
Marketing category
ANDA
Marketing start
2018-06-07
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1108-12024-01-30C16284748780-11030e365-0a5e-111a-e063-dadaa90a10e2Enalapril Maleate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1108-1Enalapril Maleate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1108ENALAPRIL MALEATE TABLET [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190118_97674aec-5e1a-40d4-b753-d38a829c550f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSN97674aec-5e1a-40d4-b753-d38a829c550f1
858813enalapril maleate 5 MG Oral TabletSCD97674aec-5e1a-40d4-b753-d38a829c550f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53808-1108-15380811080130 TABLET in 1 BLISTER PACK (53808-1108-1) 30 tablet2018-06-070000-00-00NoNoCurrent