FDA.reportPublic FDA data

ENALAPRIL MALEATE

Product NDC
50228-228
11-digit product format
502280228
Labeler code
50228
Product ID
50228-228_30905104-4d85-a4dc-e063-6394a90a120d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA075178
Marketing category
ANDA
Marketing start
2025-02-12
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, 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
50228-228-01ENALAPRIL MALEATE100 in 1 BOTTLETABLET1002
50228-228-10ENALAPRIL MALEATE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-228-01EA - Each50228-228a67c9e76-fa29-4924-a24f-4e0d5f02d53b12025-05-14
50228-228-10EA - Each50228-2282092d697-2041-424f-8e86-79ede23b7ed012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-228ENALAPRIL MALEATE TABLET [SCIEGEN PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250321_63187a94-9ac7-4320-ac70-0631e08c2b8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN63187a94-9ac7-4320-ac70-0631e08c2b8d2
858804enalapril maleate 2.5 MG Oral TabletPSN63187a94-9ac7-4320-ac70-0631e08c2b8d2
858810enalapril maleate 20 MG Oral TabletPSN63187a94-9ac7-4320-ac70-0631e08c2b8d2
858813enalapril maleate 5 MG Oral TabletPSN63187a94-9ac7-4320-ac70-0631e08c2b8d2
858817enalapril maleate 10 MG Oral TabletSCD63187a94-9ac7-4320-ac70-0631e08c2b8d2
858804enalapril maleate 2.5 MG Oral TabletSCD63187a94-9ac7-4320-ac70-0631e08c2b8d2
858810enalapril maleate 20 MG Oral TabletSCD63187a94-9ac7-4320-ac70-0631e08c2b8d2
858813enalapril maleate 5 MG Oral TabletSCD63187a94-9ac7-4320-ac70-0631e08c2b8d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50228-228-0150228022801100 TABLET in 1 BOTTLE (50228-228-01) 100 tablet2025-02-12NoNoHistorical
50228-228-10502280228101000 TABLET in 1 BOTTLE (50228-228-10) 1000 tablet2025-02-12NoNoHistorical