flecainide acetate

Generic: flecainide acetate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 100 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-661
Product ID 62135-661_25893d71-9846-59aa-e063-6294a90a3f48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079164
Listing Expiration 2026-12-31
Marketing Start 2009-07-09

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135661
Hyphenated Format 62135-661

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0362135661601 0362135662608 0362135660604
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 ANDA079164 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, GLASS (62135-661-60)
source: ndc

Packages (1)

62135-661-60 60 TABLET in 1 BOTTLE, GLASS (62135-661-60)

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": "25893d71-9846-59aa-e063-6294a90a3f48", "openfda": {"upc": ["0362135661601", "0362135662608", "0362135660604"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["a604aee4-30d5-4007-9882-98137d0d867f"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, GLASS (62135-661-60)", "package_ndc": "62135-661-60", "marketing_start_date": "20230621"}], "brand_name": "Flecainide Acetate", "product_id": "62135-661_25893d71-9846-59aa-e063-6294a90a3f48", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "62135-661", "generic_name": "Flecainide Acetate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "100 mg/1"}], "application_number": "ANDA079164", "marketing_category": "ANDA", "marketing_start_date": "20090709", "listing_expiration_date": "20261231"}