FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
63187-977
11-digit product format
631870977
Labeler code
63187
Product ID
63187-977_386e877f-e67d-4f4a-964d-ca85afc1ba32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
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
63187-977-30Enalapril Maleate30 in 1 BOTTLETABLET304
63187-977-60Enalapril Maleate60 in 1 BOTTLETABLET604
63187-977-90Enalapril Maleate90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-977-90EA - Each63187-9772a058861-3ca5-4352-ae68-d94be74586d412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-977ENALAPRIL MALEATE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200313_ca1d0143-bbd3-4041-9981-eadbb8893a2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNca1d0143-bbd3-4041-9981-eadbb8893a2b4
858810enalapril maleate 20 MG Oral TabletSCDca1d0143-bbd3-4041-9981-eadbb8893a2b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-977-306318709773030 TABLET in 1 BOTTLE (63187-977-30) 30 tablet2018-02-010000-00-00NoNoCurrent
63187-977-606318709776060 TABLET in 1 BOTTLE (63187-977-60) 60 tablet2018-02-010000-00-00NoNoCurrent
63187-977-906318709779090 TABLET in 1 BOTTLE (63187-977-90) 90 tablet2018-02-010000-00-00NoNoCurrent