Enalapril Maleate

Product NDC
72789-318
11-digit product format
727890318
Labeler code
72789
Product ID
72789-318_2e70221c-7705-77b8-e063-6394a90a32a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA213273
Marketing category
ANDA
Marketing start
2022-04-24
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-318-90Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-318-90EA - Each72789-3183ededf67-4349-4398-a9e0-3efabb26664612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-318ENALAPRIL MALEATE TABLET [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20250221_cbaaa849-0f9d-4294-b122-090ff17fdcc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858810enalapril maleate 20 MG Oral TabletPSNcbaaa849-0f9d-4294-b122-090ff17fdcc74
858810enalapril maleate 20 MG Oral TabletSCDcbaaa849-0f9d-4294-b122-090ff17fdcc74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-318-907278903189090 TABLET in 1 BOTTLE, PLASTIC (72789-318-90) 90 tablet2023-04-04NoNoHistorical