FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
50090-7302
11-digit product format
500907302
Labeler code
50090
Product ID
50090-7302_a0f89bce-9779-45e9-9934-cbfe6b2d6f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213273
Marketing category
ANDA
Marketing start
2022-04-24
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
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7302-0Enalapril Maleate30 in 1 BOTTLETABLET301
50090-7302-1Enalapril Maleate100 in 1 BOTTLETABLET1001
50090-7302-3Enalapril Maleate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7302-0EA - Each50090-7302a8c9eb73-aee4-4fb2-8407-3ecf602978de12024-11-05
50090-7302-1EA - Each50090-73026d4ef39e-bebd-4a74-8eba-cc2685d2422212024-11-05
50090-7302-3EA - Each50090-7302226add2b-7406-4687-9a6d-d54593bcebb812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7302ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241016_dfc439f7-83f5-4b9e-bbf2-f3d002860be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNdfc439f7-83f5-4b9e-bbf2-f3d002860be31
858813enalapril maleate 5 MG Oral TabletSCDdfc439f7-83f5-4b9e-bbf2-f3d002860be31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7302-05009073020030 TABLET in 1 BOTTLE (50090-7302-0) 30 tablet2024-10-14NoNoCurrent
50090-7302-150090730201100 TABLET in 1 BOTTLE (50090-7302-1) 100 tablet2024-10-14NoNoCurrent
50090-7302-35009073020390 TABLET in 1 BOTTLE (50090-7302-3) 90 tablet2024-10-14NoNoCurrent