FDA.reportPublic FDA data

Enalapril maleate

Product NDC
51655-058
11-digit product format
516550058
Labeler code
51655
Product ID
51655-058_4ab5d5ca-26c1-1c5f-e063-6394a90a00ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075479
Marketing category
ANDA
Marketing start
2022-07-11
Substance
ENALAPRIL MALEATE
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enalapril maleate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858810

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-058-262026-01-29C16284748780-149896155-bb94-586f-e063-e6dba90add90Rx only
51655-058-522026-01-29C16284748780-149896155-bb94-586f-e063-e6dba90add90Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-058-26Enalapril maleate90 in 1 BOTTLE, PLASTICTABLET904
51655-058-52Enalapril maleate30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-058ENALAPRIL MALEATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240724_f2a0bd73-0389-3f88-e053-2995a90a72e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNf2a0bd73-0389-3f88-e053-2995a90a72e84
858810enalapril maleate 20 MG Oral TabletSCDf2a0bd73-0389-3f88-e053-2995a90a72e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-058-265165500582690 TABLET in 1 BOTTLE, PLASTIC (51655-058-26) 90 tablet2022-07-11NoNoHistorical
51655-058-525165500585230 TABLET in 1 BOTTLE, PLASTIC (51655-058-52) 30 tablet2023-03-10NoNoHistorical