flecainide acetate

Generic: flecainide acetate tablet

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate tablet
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 150 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-382
Product ID 62559-382_74b708a0-2859-4efd-98a6-0c2f04d20114
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075882
Listing Expiration 2026-12-31
Marketing Start 2015-12-28

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559382
Hyphenated Format 62559-382

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0362559380010 0362559382014 0362559381017
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 tablet (source: ndc)
Application Number ANDA075882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62559-382-01)
source: ndc

Packages (1)

62559-382-01 100 TABLET in 1 BOTTLE (62559-382-01)

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": "74b708a0-2859-4efd-98a6-0c2f04d20114", "openfda": {"upc": ["0362559380010", "0362559382014", "0362559381017"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["5a12889a-52ce-4dc4-9240-22d126f071ac"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62559-382-01)", "package_ndc": "62559-382-01", "marketing_start_date": "20151228"}], "brand_name": "Flecainide Acetate", "product_id": "62559-382_74b708a0-2859-4efd-98a6-0c2f04d20114", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "62559-382", "generic_name": "Flecainide Acetate Tablet", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "150 mg/1"}], "application_number": "ANDA075882", "marketing_category": "ANDA", "marketing_start_date": "20151228", "listing_expiration_date": "20261231"}