ENALAPRIL MALEATE

Product NDC
59651-529
11-digit product format
596510529
Labeler code
59651
Product ID
59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216458
Marketing category
ANDA
Marketing start
2024-01-08
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-529-55ENALAPRIL MALEATE1 in 1 CARTONSOLUTION12
59651-529-55ENALAPRIL MALEATE150 mL in 1 BOTTLESOLUTION1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-529-55ML - Milliliter59651-5291f18ba10-1df5-4308-b6c9-6f5acbd199c012024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-529ENALAPRIL MALEATE SOLUTION [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20240124_337707cc-4ed9-4121-bfff-c5015e5eca9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSN337707cc-4ed9-4121-bfff-c5015e5eca9d2
1435624enalapril maleate 1 MG/ML Oral SolutionSCD337707cc-4ed9-4121-bfff-c5015e5eca9d2
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSY337707cc-4ed9-4121-bfff-c5015e5eca9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-529-55596510529551 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE1 bottle2024-01-08NoNoHistorical