FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
71335-9604
11-digit product format
713359604
Labeler code
71335
Product ID
71335-9604_a95d1a39-5c68-422b-bb77-a52686ebf60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213273
Marketing category
ANDA
Marketing start
2022-04-24
Substance
ENALAPRIL MALEATE
Active strength
10 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 MALEATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858817

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
71335-9604-1Enalapril Maleate60 in 1 BOTTLETABLET60102
71335-9604-2Enalapril Maleate30 in 1 BOTTLETABLET30102
71335-9604-3Enalapril Maleate100 in 1 BOTTLETABLET100102
71335-9604-4Enalapril Maleate90 in 1 BOTTLETABLET90102
71335-9604-5Enalapril Maleate120 in 1 BOTTLETABLET120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9604ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20250402_2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6102
858817enalapril maleate 10 MG Oral TabletSCD2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d6102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9604-17133596040160 TABLET in 1 BOTTLE (71335-9604-1) 60 tablet2022-12-200000-00-00NoNoCurrent
71335-9604-27133596040230 TABLET in 1 BOTTLE (71335-9604-2) 30 tablet2022-12-200000-00-00NoNoCurrent
71335-9604-371335960403100 TABLET in 1 BOTTLE (71335-9604-3) 100 tablet2022-12-200000-00-00NoNoCurrent
71335-9604-47133596040490 TABLET in 1 BOTTLE (71335-9604-4) 90 tablet2022-12-200000-00-00NoNoCurrent
71335-9604-571335960405120 TABLET in 1 BOTTLE (71335-9604-5) 120 tablet2022-12-200000-00-00NoNoCurrent