flecainide acetate

Generic: flecainide acetate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flecainide acetate
Generic Name flecainide acetate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

flecainide acetate 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-385
Product ID 72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210683
Listing Expiration 2027-12-31
Marketing Start 2024-01-11

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789385
Hyphenated Format 72789-385

Supplemental Identifiers

RxCUI
886662
UNII
M8U465Q1WQ

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 ANDA210683 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-385-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93)
source: ndc

Packages (3)

72789-385-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01) 72789-385-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-385-60) 72789-385-93 180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93)

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": "4bc04d15-e3ce-d29c-e063-6294a90a0103", "openfda": {"unii": ["M8U465Q1WQ"], "rxcui": ["886662"], "spl_set_id": ["2b336028-1e13-4ef7-b75e-345bc9c06f9a"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01)", "package_ndc": "72789-385-01", "marketing_start_date": "20240227"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-385-60)", "package_ndc": "72789-385-60", "marketing_start_date": "20240227"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93)", "package_ndc": "72789-385-93", "marketing_start_date": "20240227"}], "brand_name": "Flecainide Acetate", "product_id": "72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "72789-385", "generic_name": "flecainide acetate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flecainide Acetate", "active_ingredients": [{"name": "FLECAINIDE ACETATE", "strength": "50 mg/1"}], "application_number": "ANDA210683", "marketing_category": "ANDA", "marketing_start_date": "20240111", "listing_expiration_date": "20271231"}