flecainide acetate

Generic: flecainide acetate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 150 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-623
Product ID 65862-623_c100187f-d40e-4ffe-aab7-068a9f3bd7b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202821
Listing Expiration 2026-12-31
Marketing Start 2017-11-03

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862623
Hyphenated Format 65862-623

Supplemental Identifiers

RxCUI
886662 886666 886671
UPC
0365862622303 0365862621306 0365862623300
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 ANDA202821 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-623-01)
  • 30 TABLET in 1 BOTTLE (65862-623-30)
  • 1000 TABLET in 1 BOTTLE (65862-623-99)
source: ndc

Packages (3)

65862-623-01 100 TABLET in 1 BOTTLE (65862-623-01) 65862-623-30 30 TABLET in 1 BOTTLE (65862-623-30) 65862-623-99 1000 TABLET in 1 BOTTLE (65862-623-99)

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": "c100187f-d40e-4ffe-aab7-068a9f3bd7b9", "openfda": {"upc": ["0365862622303", "0365862621306", "0365862623300"], "unii": ["M8U465Q1WQ"], "rxcui": ["886662", "886666", "886671"], "spl_set_id": ["14e89448-3a18-42e3-8537-2589be1ef94e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-623-01)", "package_ndc": "65862-623-01", "marketing_start_date": "20171103"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-623-30)", "package_ndc": "65862-623-30", "marketing_start_date": "20171103"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-623-99)", "package_ndc": "65862-623-99", "marketing_start_date": "20171103"}], "brand_name": "Flecainide Acetate", "product_id": "65862-623_c100187f-d40e-4ffe-aab7-068a9f3bd7b9", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "65862-623", "generic_name": "Flecainide Acetate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "150 mg/1"}], "application_number": "ANDA202821", "marketing_category": "ANDA", "marketing_start_date": "20171103", "listing_expiration_date": "20261231"}