FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
50090-6712
11-digit product format
500906712
Labeler code
50090
Product ID
50090-6712_3e169e78-d7e0-47c1-aa4e-00090b8f34e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
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
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6712-0Enalapril Maleate30 in 1 BOTTLETABLET302
50090-6712-1Enalapril Maleate100 in 1 BOTTLETABLET1002
50090-6712-4Enalapril Maleate90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6712ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20231003_f3754f29-9b75-4e2c-9c28-b3479f5bf906.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNf3754f29-9b75-4e2c-9c28-b3479f5bf9062
858817enalapril maleate 10 MG Oral TabletSCDf3754f29-9b75-4e2c-9c28-b3479f5bf9062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6712-05009067120030 TABLET in 1 BOTTLE (50090-6712-0) 30 tablet2023-09-28NoNoCurrent
50090-6712-150090671201100 TABLET in 1 BOTTLE (50090-6712-1) 100 tablet2023-09-28NoNoCurrent
50090-6712-45009067120490 TABLET in 1 BOTTLE (50090-6712-4) 90 tablet2023-09-28NoNoCurrent