ENALAPRIL MALEATE

Product NDC
50090-7677
11-digit product format
500907677
Labeler code
50090
Product ID
50090-7677_68698c51-6c2c-425e-a681-fbb382d79968
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
20 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 MALEATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858810

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
50090-7677-0ENALAPRIL MALEATE30 in 1 BOTTLETABLET301
50090-7677-1ENALAPRIL MALEATE60 in 1 BOTTLETABLET601
50090-7677-3ENALAPRIL MALEATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7677-0EA - Each50090-76772f64df0d-48fb-4fb7-b60a-58323e6e6c0e12025-12-16
50090-7677-1EA - Each50090-7677d763c497-a8a0-4700-b98f-adda9f69d51012025-12-16
50090-7677-3EA - Each50090-7677efb4e6d6-3a59-409c-913b-72055509d97512025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNfd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df31
858810enalapril maleate 20 MG Oral TabletSCDfd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7677-05009076770030 TABLET in 1 BOTTLE (50090-7677-0) 30 tablet2025-10-08NoNoCurrent
50090-7677-15009076770160 TABLET in 1 BOTTLE (50090-7677-1) 60 tablet2025-10-08NoNoCurrent
50090-7677-35009076770390 TABLET in 1 BOTTLE (50090-7677-3) 90 tablet2025-10-08NoNoCurrent