FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
71335-1910
11-digit product format
713351910
Labeler code
71335
Product ID
71335-1910_5aa8f072-39b8-4c7d-b80f-5b1d938ecada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enalapril Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1910-1Enalapril Maleate150 in 1 BOTTLETABLET150102
71335-1910-2Enalapril Maleate100 in 1 BOTTLETABLET100102
71335-1910-3Enalapril Maleate30 in 1 BOTTLETABLET30102
71335-1910-4Enalapril Maleate60 in 1 BOTTLETABLET60102
71335-1910-5Enalapril Maleate90 in 1 BOTTLETABLET90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1910ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240415_bdb34c96-1532-4ce5-93a7-3cc90904c910.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNbdb34c96-1532-4ce5-93a7-3cc90904c910102
858813enalapril maleate 5 MG Oral TabletSCDbdb34c96-1532-4ce5-93a7-3cc90904c910102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1910-171335191001150 TABLET in 1 BOTTLE (71335-1910-1) 150 tablet2024-04-050000-00-00NoNoCurrent
71335-1910-271335191002100 TABLET in 1 BOTTLE (71335-1910-2) 100 tablet2023-10-270000-00-00NoNoCurrent
71335-1910-37133519100330 TABLET in 1 BOTTLE (71335-1910-3) 30 tablet2021-09-170000-00-00NoNoCurrent
71335-1910-47133519100460 TABLET in 1 BOTTLE (71335-1910-4) 60 tablet2024-04-050000-00-00NoNoCurrent
71335-1910-57133519100590 TABLET in 1 BOTTLE (71335-1910-5) 90 tablet2021-08-110000-00-00NoNoCurrent