FDA.reportPublic FDA data

Enalapril maleate

Product NDC
51655-110
11-digit product format
516550110
Labeler code
51655
Product ID
51655-110_4abaaa3b-589e-a03d-e063-6394a90a0b86
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
2022-09-07
Substance
ENALAPRIL MALEATE
Active strength
5 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 MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858813

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
51655-110-262026-01-29C16284748780-149896155-ab15-586f-e063-e6dba90add90Rx only
51655-110-522026-01-29C16284748780-149896155-ab15-586f-e063-e6dba90add90Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-110-26Enalapril maleate90 in 1 BOTTLE, PLASTICTABLET904
51655-110-52Enalapril maleate30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-110ENALAPRIL MALEATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241215_f2b3776b-02a1-311b-e053-2a95a90a2f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNf2b3776b-02a1-311b-e053-2a95a90a2f9b4
858813enalapril maleate 5 MG Oral TabletSCDf2b3776b-02a1-311b-e053-2a95a90a2f9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-110-265165501102690 TABLET in 1 BOTTLE, PLASTIC (51655-110-26) 90 tablet2022-09-07NoNoCurrent
51655-110-525165501105230 TABLET in 1 BOTTLE, PLASTIC (51655-110-52) 30 tablet2022-10-17NoNoCurrent