FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
63629-7895
11-digit product format
636297895
Labeler code
63629
Product ID
63629-7895_92467f85-2fc5-483b-8d1c-10c67d8ff9b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
Substance
ENALAPRIL MALEATE
Active strength
2.5 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 MALEATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858804, 858810, 858817

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
63629-7895-1Enalapril Maleate30 in 1 BOTTLETABLET301032
63629-7895-2Enalapril Maleate90 in 1 BOTTLETABLET901032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7895-1EA - Each63629-7895321364d4-39c1-4abf-b604-c4b434ce50dc12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7895ENALAPRIL MALEATE TABLET [BRYANT RANCH PREPACK]1031Current NDC, Legacy NDC, 2 package rows20231005_fb3c7066-76cb-4e8e-b98b-bcb41a3631df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032
858804enalapril maleate 2.5 MG Oral TabletPSNfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032
858810enalapril maleate 20 MG Oral TabletPSNfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032
858817enalapril maleate 10 MG Oral TabletSCDfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032
858804enalapril maleate 2.5 MG Oral TabletSCDfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032
858810enalapril maleate 20 MG Oral TabletSCDfb3c7066-76cb-4e8e-b98b-bcb41a3631df1032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7895-16362978950130 TABLET in 1 BOTTLE (63629-7895-1) 30 tablet2019-01-150000-00-00NoNoCurrent
63629-7895-26362978950290 TABLET in 1 BOTTLE (63629-7895-2) 90 tablet2019-01-150000-00-00NoNoCurrent