Enalapril maleate oral solution

Product NDC
31722-020
11-digit product format
317220020
Labeler code
31722
Product ID
31722-020_d7a8fe4e-7b8e-05b0-e053-2995a90a6291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214467
Marketing category
ANDA
Marketing start
2022-02-14
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-020-15Enalapril maleate oral solution150 mL in 1 BOTTLESOLUTION1501
31722-020-15Enalapril maleate oral solution1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-020ENALAPRIL MALEATE ORAL SOLUTION (ENALAPRIL MALEATE) SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20220226_b63bdaa6-b57b-417b-9a79-29f1fd5bbf08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSNb63bdaa6-b57b-417b-9a79-29f1fd5bbf081
1435624enalapril maleate 1 MG/ML Oral SolutionSCDb63bdaa6-b57b-417b-9a79-29f1fd5bbf081
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSYb63bdaa6-b57b-417b-9a79-29f1fd5bbf081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-020-15317220020151 BOTTLE in 1 CARTON (31722-020-15) / 150 mL in 1 BOTTLE1 bottle2022-02-140000-00-00NoNoCurrent