flecainide acetate

Generic: flecainide acetate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 100 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0011
Product ID 0054-0011_e34a6adf-8794-426e-9e43-11060803a90d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076278
Listing Expiration 2026-12-31
Marketing Start 2003-01-14

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540011
Hyphenated Format 0054-0011

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0300540011215
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 ANDA076278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0054-0011-20) / 1 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (0054-0011-21)
  • 100 TABLET in 1 BOTTLE (0054-0011-25)
source: ndc

Packages (3)

0054-0011-20 100 BLISTER PACK in 1 CARTON (0054-0011-20) / 1 TABLET in 1 BLISTER PACK 0054-0011-21 60 TABLET in 1 BOTTLE (0054-0011-21) 0054-0011-25 100 TABLET in 1 BOTTLE (0054-0011-25)

Ingredients (1)

flecainide acetate (100 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": "e34a6adf-8794-426e-9e43-11060803a90d", "openfda": {"upc": ["0300540011215"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["4f6b78d4-8ac8-464b-bb78-ee70cbc97898"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0054-0011-20)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0054-0011-20", "marketing_start_date": "20030114"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0054-0011-21)", "package_ndc": "0054-0011-21", "marketing_start_date": "20030114"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0011-25)", "package_ndc": "0054-0011-25", "marketing_start_date": "20030114"}], "brand_name": "Flecainide Acetate", "product_id": "0054-0011_e34a6adf-8794-426e-9e43-11060803a90d", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "0054-0011", "generic_name": "flecainide acetate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "100 mg/1"}], "application_number": "ANDA076278", "marketing_category": "ANDA", "marketing_start_date": "20030114", "listing_expiration_date": "20261231"}