flecainide acetate

Generic: flecainide acetate

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 150 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-819
Product ID 42806-819_44e0bf64-72e3-4168-e063-6294a90a3934
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215599
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806819
Hyphenated Format 42806-819

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0342806818015 0342806817018 0342806819012
UNII
M8U465Q1WQ

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 flecainide acetate (source: ndc)
Generic Name flecainide acetate (source: ndc)
Application Number ANDA215599 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-819-01)
source: ndc

Packages (1)

42806-819-01 100 TABLET in 1 BOTTLE (42806-819-01)

Ingredients (1)

flecainide acetate (150 mg/1)

Linked Drug Pages (1)

Flecainide Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44e0bf64-72e3-4168-e063-6294a90a3934", "openfda": {"upc": ["0342806818015", "0342806817018", "0342806819012"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-819-01)", "package_ndc": "42806-819-01", "marketing_start_date": "20220915"}], "brand_name": "Flecainide Acetate", "product_id": "42806-819_44e0bf64-72e3-4168-e063-6294a90a3934", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "42806-819", "generic_name": "flecainide acetate", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "150 mg/1"}], "application_number": "ANDA215599", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}