Enalapril Maleate

Product NDC
69238-2141
11-digit product format
692382141
Labeler code
69238
Product ID
69238-2141_ddab86a7-99c5-4f3d-9bc9-bfd33b2886e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril
Dosage form
SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA208686
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-03-23
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
69238-2141-7Enalapril Maleate1 in 1 CARTONSOLUTION14
69238-2141-7Enalapril Maleate150 mL in 1 BOTTLESOLUTION1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2141-7ML - Milliliter69238-214174dc6d56-5819-4b25-a62f-8f5e2b7ff37312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2141ENALAPRIL MALEATE (ENALAPRIL) SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 2 package rows20231230_7efed863-919d-458e-99e1-ce0cec95537a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSN7efed863-919d-458e-99e1-ce0cec95537a4
1435624enalapril maleate 1 MG/ML Oral SolutionSCD7efed863-919d-458e-99e1-ce0cec95537a4
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSY7efed863-919d-458e-99e1-ce0cec95537a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2141-7692382141071 BOTTLE in 1 CARTON (69238-2141-7) / 150 mL in 1 BOTTLE1 bottle2022-03-230000-00-00NoNoCurrent