ENALAPRIL MALEATE

Product NDC
50090-7678
11-digit product format
500907678
Labeler code
50090
Product ID
50090-7678_40869a3b-6045-4595-98fa-d95fbce2fba0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075178
Marketing category
ANDA
Marketing start
2025-02-12
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
50090-7678-0ENALAPRIL MALEATE30 in 1 BOTTLETABLET301
50090-7678-1ENALAPRIL MALEATE100 in 1 BOTTLETABLET1001
50090-7678-4ENALAPRIL MALEATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7678-0EA - Each50090-7678fa7ab9bc-01ed-4e79-8b37-488abbdc993012025-12-16
50090-7678-1EA - Each50090-76786a11c985-74d7-43c3-95f7-06cf8699ed2a12025-12-16
50090-7678-4EA - Each50090-7678180e170b-c664-49e9-8a93-64583d45e10712025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNaafdb635-fa17-4bfb-bcd3-86c7e7b147e21
858817enalapril maleate 10 MG Oral TabletSCDaafdb635-fa17-4bfb-bcd3-86c7e7b147e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7678-05009076780030 TABLET in 1 BOTTLE (50090-7678-0) 30 tablet2025-10-08NoNoCurrent
50090-7678-150090767801100 TABLET in 1 BOTTLE (50090-7678-1) 100 tablet2025-10-08NoNoCurrent
50090-7678-45009076780490 TABLET in 1 BOTTLE (50090-7678-4) 90 tablet2025-10-08NoNoCurrent