flecainide acetate

Generic: flecainide acetate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 50 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-641
Product ID 53746-641_fe4cd965-0740-40bc-a301-26e337c8406e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075442
Listing Expiration 2026-12-31
Marketing Start 2009-12-01

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746641
Hyphenated Format 53746-641

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0353746643018
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 ANDA075442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-641-01)
  • 1000 TABLET in 1 BOTTLE (53746-641-10)
source: ndc

Packages (2)

53746-641-01 100 TABLET in 1 BOTTLE (53746-641-01) 53746-641-10 1000 TABLET in 1 BOTTLE (53746-641-10)

Ingredients (1)

flecainide acetate (50 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": "fe4cd965-0740-40bc-a301-26e337c8406e", "openfda": {"upc": ["0353746643018"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["ee9595d5-08a1-4529-9215-ddc3c7f929c4"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-641-01)", "package_ndc": "53746-641-01", "marketing_start_date": "20091201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-641-10)", "package_ndc": "53746-641-10", "marketing_start_date": "20091201"}], "brand_name": "Flecainide Acetate", "product_id": "53746-641_fe4cd965-0740-40bc-a301-26e337c8406e", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "53746-641", "generic_name": "Flecainide Acetate", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "50 mg/1"}], "application_number": "ANDA075442", "marketing_category": "ANDA", "marketing_start_date": "20091201", "listing_expiration_date": "20261231"}