FDA.reportPublic FDA data

Enalapril maleate

Product NDC
23155-704
11-digit product format
231550704
Labeler code
23155
Product ID
23155-704_f59f9ce5-246c-47c9-a171-aee4cc1c09a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA075479
Marketing category
ANDA
Marketing start
2020-04-28
Substance
ENALAPRIL MALEATE
Active strength
2.5 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
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 MALEATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858804, 858810, 858813, 858817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-704-01Enalapril maleate100 in 1 BOTTLETABLET1007
23155-704-10Enalapril maleate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-704-01EA - Each23155-7041feeec95-e944-4a68-bcfc-673c7539a94a12020-08-06
23155-704-10EA - Each23155-704fea846de-237c-49bc-840e-e79d5422e2ac12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-704ENALAPRIL MALEATE TABLET ENALAPRIL MALEATE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20240301_5c49fb37-1f09-4965-b213-5580d3a30a11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858804enalapril maleate 2.5 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858810enalapril maleate 20 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858813enalapril maleate 5 MG Oral TabletPSN5c49fb37-1f09-4965-b213-5580d3a30a117
858817enalapril maleate 10 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858804enalapril maleate 2.5 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858810enalapril maleate 20 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858813enalapril maleate 5 MG Oral TabletSCD5c49fb37-1f09-4965-b213-5580d3a30a117
858817enalapril maleate 10 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858804enalapril maleate 2.5 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858810enalapril maleate 20 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858813enalapril maleate 5 MG Oral TabletPSN8fe8dc52-dee6-4d33-b798-e90128011f463
858817enalapril maleate 10 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858804enalapril maleate 2.5 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858810enalapril maleate 20 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463
858813enalapril maleate 5 MG Oral TabletSCD8fe8dc52-dee6-4d33-b798-e90128011f463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-704-0123155070401100 TABLET in 1 BOTTLE (23155-704-01) 100 tablet2020-04-280000-00-00NoNoCurrent
23155-704-10231550704101000 TABLET in 1 BOTTLE (23155-704-10) 1000 tablet2020-04-280000-00-00NoNoCurrent