Enalapril Maleate

Product NDC
70518-4197
11-digit product format
705184197
Labeler code
70518
Product ID
70518-4197_39e3f37a-6015-7d85-e063-6294a90a18bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213273
Marketing category
ANDA
Marketing start
2024-10-01
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9O25354EPJENALAPRIL MALEATE76095-16-4ENALAPRIL MALEATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4197-07051841970090 TABLET in 1 BOTTLE, PLASTIC (70518-4197-0) 90 tablet2024-10-01NoNoHistorical
70518-4197-17051841970130 TABLET in 1 BLISTER PACK (70518-4197-1) 30 tablet2025-05-03NoNoHistorical
70518-4197-27051841970290 TABLET in 1 BOTTLE, PLASTIC (70518-4197-2) 90 tablet2025-07-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ENALAPRIL MALEATE TABLETS Rx onlyREMEDYREPACK INC.2025-07-14HUMAN PRESCRIPTION DRUG LABEL4