Enalapril maleate

Product NDC
52536-401
11-digit product format
525360401
Labeler code
52536
Product ID
52536-401_461e14b2-890d-011c-e063-6294a90a0d4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
Wilshire Pharmaceuticals, Inc.
Application
NDA208686
Marketing category
NDA
Marketing start
2024-04-08
Substance
ENALAPRIL MALEATE
Active strength
1 mg/mL
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 MALEATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui1435624

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
52536-401-01Enalapril maleate1 in 1 CARTONSOLUTION12
52536-401-01Enalapril maleate150 mL in 1 BOTTLESOLUTION1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-401-01ML - Milliliter52536-401f082d63b-9d07-47a1-9cd6-8dbb6eee87cd12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-401ENALAPRIL MALEATE SOLUTION [WILSHIRE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240413_c7934b45-eb6b-44c1-bd2c-ef0fa10850c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSNc7934b45-eb6b-44c1-bd2c-ef0fa10850c12
1435624enalapril maleate 1 MG/ML Oral SolutionSCDc7934b45-eb6b-44c1-bd2c-ef0fa10850c12
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSYc7934b45-eb6b-44c1-bd2c-ef0fa10850c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52536-401-01525360401011 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE1 bottle2024-04-08NoNoHistorical