enalapril maleate

Generic: enalapril maleate

Labeler: amici pharma, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name enalapril maleate
Generic Name enalapril maleate
Labeler amici pharma, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

enalapril maleate 2.5 mg/1

Manufacturer
Amici Pharma, Inc

Identifiers & Regulatory

Product NDC 69292-540
Product ID 69292-540_d6d5b131-5d92-41b7-829f-9de587a951d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075483
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

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 69292540
Hyphenated Format 69292-540

Supplemental Identifiers

RxCUI
858804 858810 858813 858817
UPC
0369292546017 0369292540015 0369292540107 0369292542019
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 ANDA075483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69292-540-01)
  • 1000 TABLET in 1 BOTTLE (69292-540-10)
source: ndc

Packages (2)

69292-540-01 100 TABLET in 1 BOTTLE (69292-540-01) 69292-540-10 1000 TABLET in 1 BOTTLE (69292-540-10)

Ingredients (1)

enalapril maleate (2.5 mg/1)

Linked Drug Pages (1)

ENALAPRIL MALEATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d6d5b131-5d92-41b7-829f-9de587a951d6", "openfda": {"upc": ["0369292546017", "0369292540015", "0369292540107", "0369292542019"], "unii": ["9O25354EPJ"], "rxcui": ["858804", "858810", "858813", "858817"], "spl_set_id": ["a88902bd-742f-4ea6-b625-cc9df1709efc"], "manufacturer_name": ["Amici Pharma, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69292-540-01)", "package_ndc": "69292-540-01", "marketing_start_date": "20251015"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69292-540-10)", "package_ndc": "69292-540-10", "marketing_start_date": "20251015"}], "brand_name": "ENALAPRIL MALEATE", "product_id": "69292-540_d6d5b131-5d92-41b7-829f-9de587a951d6", "dosage_form": "TABLET", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Decreased Blood Pressure [PE]"], "product_ndc": "69292-540", "generic_name": "enalapril maleate", "labeler_name": "Amici Pharma, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENALAPRIL MALEATE", "active_ingredients": [{"name": "ENALAPRIL MALEATE", "strength": "2.5 mg/1"}], "application_number": "ANDA075483", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}