FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
70518-3572
11-digit product format
705183572
Labeler code
70518
Product ID
70518-3572_4f5b100a-b070-5907-e063-6294a90a270c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213273
Marketing category
ANDA
Marketing start
2022-11-07
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
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
70518-3572-0Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET907
70518-3572-1Enalapril Maleate30 in 1 BLISTER PACKTABLET307
70518-3572-2Enalapril Maleate30 in 1 BLISTER PACKTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3572ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 3 package rows20250306_1b464099-491d-473b-836e-9d86b2b1eeec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSN1b464099-491d-473b-836e-9d86b2b1eeec7
858813enalapril maleate 5 MG Oral TabletSCD1b464099-491d-473b-836e-9d86b2b1eeec7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3572-07051835720090 TABLET in 1 BOTTLE, PLASTIC (70518-3572-0) 90 tablet2022-11-070000-00-00NoNoCurrent
70518-3572-17051835720130 in 1 BLISTER PACKHistorical
70518-3572-27051835720230 TABLET in 1 BLISTER PACK (70518-3572-2) 30 tablet2025-05-28NoNoCurrent