enalapril maleate

Generic: enalapril maleate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enalapril maleate
Generic Name enalapril maleate
Labeler aurobindo pharma limited
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

enalapril maleate 1 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-529
Product ID 59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216458
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

Pharmacologic Class

Classes
angiotensin converting enzyme inhibitor [epc] angiotensin-converting enzyme inhibitors [moa] decreased blood pressure [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651529
Hyphenated Format 59651-529

Supplemental Identifiers

RxCUI
1435624
UNII
9O25354EPJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enalapril maleate (source: ndc)
Generic Name enalapril maleate (source: ndc)
Application Number ANDA216458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-529-55 1 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE

Ingredients (1)

enalapril maleate (1 mg/mL)

Linked Drug Pages (1)

ENALAPRIL MALEATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2", "openfda": {"unii": ["9O25354EPJ"], "rxcui": ["1435624"], "spl_set_id": ["337707cc-4ed9-4121-bfff-c5015e5eca9d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-529-55)  / 150 mL in 1 BOTTLE", "package_ndc": "59651-529-55", "marketing_start_date": "20240108"}], "brand_name": "ENALAPRIL MALEATE", "product_id": "59651-529_2b0fd0eb-c717-4d3d-8c1a-5445bf64a7a2", "dosage_form": "SOLUTION", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Decreased Blood Pressure [PE]"], "product_ndc": "59651-529", "generic_name": "ENALAPRIL MALEATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENALAPRIL MALEATE", "active_ingredients": [{"name": "ENALAPRIL MALEATE", "strength": "1 mg/mL"}], "application_number": "ANDA216458", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}