enalapril maleate oral solution (69452-237)

Drug Facts

Product Profile

Brand Name enalapril maleate oral solution

Generic Name enalapril maleate

Labeler bionpharma inc.

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

enalapril maleate 1 mg/mL

Manufacturer

Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-237

Product ID 69452-237_23614d4e-d023-1bfc-e063-6394a90a42be

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212408

Listing Expiration 2026-12-31

Marketing Start 2021-08-11

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 69452237

Hyphenated Format 69452-237

Supplemental Identifiers

RxCUI

1435624

UPC

0369452237465

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 oral solution (source: ndc)

Generic Name enalapril maleate (source: ndc)

Application Number ANDA212408 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (69452-237-46) / 150 mL in 1 BOTTLE

source: ndc

Packages (1)

69452-237-46 1 BOTTLE in 1 CARTON (69452-237-46) / 150 mL in 1 BOTTLE

Ingredients (1)

enalapril maleate (1 mg/mL)

Linked Drug Pages (1)

Enalapril maleate oral solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "23614d4e-d023-1bfc-e063-6394a90a42be", "openfda": {"upc": ["0369452237465"], "unii": ["9O25354EPJ"], "rxcui": ["1435624"], "spl_set_id": ["9391b8d8-2217-4838-8976-1a5ad90ef4ca"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-237-46)  / 150 mL in 1 BOTTLE", "package_ndc": "69452-237-46", "marketing_start_date": "20210811"}], "brand_name": "Enalapril maleate oral solution", "product_id": "69452-237_23614d4e-d023-1bfc-e063-6394a90a42be", "dosage_form": "SOLUTION", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Decreased Blood Pressure [PE]"], "product_ndc": "69452-237", "generic_name": "Enalapril maleate", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enalapril maleate oral solution", "active_ingredients": [{"name": "ENALAPRIL MALEATE", "strength": "1 mg/mL"}], "application_number": "ANDA212408", "marketing_category": "ANDA", "marketing_start_date": "20210811", "listing_expiration_date": "20261231"}