FDA.reportPublic FDA data

Enalapril maleate

Product NDC
50090-6437
11-digit product format
500906437
Labeler code
50090
Product ID
50090-6437_6af69041-a80f-45e8-8f0a-eb9c5a58d723
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075479
Marketing category
ANDA
Marketing start
2020-10-01
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
50090-6437-0Enalapril maleate30 in 1 BOTTLETABLET303
50090-6437-1Enalapril maleate60 in 1 BOTTLETABLET603
50090-6437-3Enalapril maleate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6437-0EA - Each50090-64376037864a-ae1b-496a-9012-a129b96e7a0e12023-06-06
50090-6437-1EA - Each50090-6437eb8c2e71-1e55-4f57-99bc-5d8a43ad7d8c12023-06-06
50090-6437-3EA - Each50090-643710ae5179-82a4-4697-9cf6-59fbdbc3887d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6437ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20230505_ccdd0f67-e9d5-41e3-93d5-94b9792a6f8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNccdd0f67-e9d5-41e3-93d5-94b9792a6f8f3
858810enalapril maleate 20 MG Oral TabletSCDccdd0f67-e9d5-41e3-93d5-94b9792a6f8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6437-05009064370030 TABLET in 1 BOTTLE (50090-6437-0) 30 tablet2023-04-14NoNoCurrent
50090-6437-15009064370160 TABLET in 1 BOTTLE (50090-6437-1) 60 tablet2023-04-26NoNoCurrent
50090-6437-35009064370390 TABLET in 1 BOTTLE (50090-6437-3) 90 tablet2023-04-26NoNoCurrent