FDA.reportPublic FDA data

ENALAPRIL MALEATE

Product NDC
53808-0242
11-digit product format
538080242
Labeler code
53808
Product ID
53808-0242_23f7f4ad-800c-4d98-a604-3c45b2842841
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA075483
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0242-12019-10-21C16284748780-1956f9ecf-d70a-621f-e053-dbdaa90a74addd7f12a7-7fe5-470b-b151-6ccf19945638

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0242-1ENALAPRIL MALEATE30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ENALAPRILACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0242ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100805_dd7f12a7-7fe5-470b-b151-6ccf19945638.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNdd7f12a7-7fe5-470b-b151-6ccf199456381
858804enalapril maleate 2.5 MG Oral TabletPSNdd7f12a7-7fe5-470b-b151-6ccf199456381
858810enalapril maleate 20 MG Oral TabletPSNdd7f12a7-7fe5-470b-b151-6ccf199456381
858813enalapril maleate 5 MG Oral TabletPSNdd7f12a7-7fe5-470b-b151-6ccf199456381
858817enalapril maleate 10 MG Oral TabletSCDdd7f12a7-7fe5-470b-b151-6ccf199456381
858804enalapril maleate 2.5 MG Oral TabletSCDdd7f12a7-7fe5-470b-b151-6ccf199456381
858810enalapril maleate 20 MG Oral TabletSCDdd7f12a7-7fe5-470b-b151-6ccf199456381
858813enalapril maleate 5 MG Oral TabletSCDdd7f12a7-7fe5-470b-b151-6ccf199456381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0242-15380802420130 in 1 BLISTER PACKHistorical