Enalapril Maleate

Product NDC
68071-1793
11-digit product format
680711793
Labeler code
68071
Product ID
68071-1793_2d82d852-5325-2c9f-e063-6394a90a670c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213273
Marketing category
ANDA
Marketing start
2022-04-24
Substance
ENALAPRIL MALEATE
Active strength
10 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
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 MALEATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858817

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
68071-1793-12025-02-06C16284748780-12cef2736-9bf0-d83d-e063-dadaa90ab31fENALAPRIL MALEATE TABLETS Rx only
68071-1793-12025-01-30C16284748780-12cef2736-9bf0-d83d-e063-dadaa90ab31fENALAPRIL MALEATE TABLETS Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1793-1Enalapril Maleate100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1793ENALAPRIL MALEATE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250209_fd013f06-3456-c178-e053-6294a90a6bd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNfd013f06-3456-c178-e053-6294a90a6bd92
858817enalapril maleate 10 MG Oral TabletSCDfd013f06-3456-c178-e053-6294a90a6bd92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-1793-168071179301100 TABLET in 1 BOTTLE (68071-1793-1) 100 tablet2023-05-31NoNoHistorical