Enalapril Maleate Oral Solution

Product NDC
67877-712
11-digit product format
678770712
Labeler code
67877
Product ID
67877-712_2e148a1a-d7b9-4b13-9663-30d4fa2ba476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA213714
Marketing category
ANDA
Marketing start
2022-09-05
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 Oral Solution
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
67877-712-81Enalapril Maleate Oral Solution150 mL in 1 BOTTLESOLUTION1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-712ENALAPRIL MALEATE ORAL SOLUTION SOLUTION [ASCEND LABORATORIES, LLC]3Current NDC, Legacy NDC, 1 package rows20220908_964d561a-2e04-4ad9-9762-932419ee19ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSN964d561a-2e04-4ad9-9762-932419ee19ae3
1435624enalapril maleate 1 MG/ML Oral SolutionSCD964d561a-2e04-4ad9-9762-932419ee19ae3
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSY964d561a-2e04-4ad9-9762-932419ee19ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-712-8167877071281150 mL in 1 BOTTLE (67877-712-81) 150 ml2022-09-050000-00-00NoNoCurrent