FDA.reportPublic FDA data

ENALAPRIL MALEATE

Product NDC
61919-813
11-digit product format
619190813
Labeler code
61919
Product ID
61919-813_b1a82d7f-ada7-ecc5-e053-2995a90a089f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
NDA018998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-04-30
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
No
Listing certified through
2021-12-31
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
61919-813-302025-01-30C16284748780-12cef2736-74d0-d83d-e063-dadaa90ab31fENALAPRIL MALEATE
61919-813-902025-01-30C16284748780-12cef2736-74d0-d83d-e063-dadaa90ab31fENALAPRIL MALEATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-813-30ENALAPRIL MALEATE30 in 1 BOTTLETABLET308
61919-813-90ENALAPRIL MALEATE90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-813-30EA - Each61919-813901a3121-0f62-4ebc-8662-b786dbda654912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-813ENALAPRIL MALEATE TABLET [DIRECT RX]8Legacy NDC, 2 package rows20230524_4984b255-e03b-0f7b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858804enalapril maleate 2.5 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858810enalapril maleate 20 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858813enalapril maleate 5 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858804enalapril maleate 2.5 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888
858810enalapril maleate 20 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888
858813enalapril maleate 5 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-813-306191908133030 TABLET in 1 BOTTLE (61919-813-30) 30 tablet2019-04-300000-00-00NoNoCurrent
61919-813-906191908139090 TABLET in 1 BOTTLE (61919-813-90) 90 tablet2019-04-300000-00-00NoNoCurrent