ENALAPRIL MALEATE

Product NDC
69292-542
11-digit product format
692920542
Labeler code
69292
Product ID
69292-542_d6d5b131-5d92-41b7-829f-9de587a951d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharma, Inc
Application
ANDA075483
Marketing category
ANDA
Marketing start
2025-10-15
Substance
ENALAPRIL MALEATE
Active strength
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 MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858804, 858810, 858813, 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
69292-542-01ENALAPRIL MALEATE100 in 1 BOTTLETABLET1002
69292-542-10ENALAPRIL MALEATE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-542-01EA - Each69292-542c591a61b-a642-443e-9df9-4470da53e69712025-11-13
69292-542-10EA - Each69292-542e809ba7c-76f2-41bd-ad0a-5b45cc3583f212025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNa88902bd-742f-4ea6-b625-cc9df1709efc2
858804enalapril maleate 2.5 MG Oral TabletPSNa88902bd-742f-4ea6-b625-cc9df1709efc2
858810enalapril maleate 20 MG Oral TabletPSNa88902bd-742f-4ea6-b625-cc9df1709efc2
858813enalapril maleate 5 MG Oral TabletPSNa88902bd-742f-4ea6-b625-cc9df1709efc2
858817enalapril maleate 10 MG Oral TabletSCDa88902bd-742f-4ea6-b625-cc9df1709efc2
858804enalapril maleate 2.5 MG Oral TabletSCDa88902bd-742f-4ea6-b625-cc9df1709efc2
858810enalapril maleate 20 MG Oral TabletSCDa88902bd-742f-4ea6-b625-cc9df1709efc2
858813enalapril maleate 5 MG Oral TabletSCDa88902bd-742f-4ea6-b625-cc9df1709efc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-542-0169292054201100 TABLET in 1 BOTTLE (69292-542-01) 100 tablet2025-10-15NoNoCurrent
69292-542-10692920542101000 TABLET in 1 BOTTLE (69292-542-10) 1000 tablet2025-10-15NoNoCurrent