Flecainide Acetate

Orange BookUNIISPLATC C01BC04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC01BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7278938501
100 TABLET in 1 BOTTLE, PLASTIC (72789-385-01)
ndc11
7278938560
60 TABLET in 1 BOTTLE, PLASTIC (72789-385-60)
ndc11
7278938593
180 TABLET in 1 BOTTLE, PLASTIC (72789-385-93)

Annotations

UNII (FDA Substance ID)

M8U465Q1WQ

FLECAINIDE ACETATE

RxCUI 42686

Orange Book

A210683

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M8U465Q1WQ",
    "rxcui": "42686",
    "inchikey": "RKXNZRPQSOPPRN-UHFFFAOYSA-N",
    "display_name": "FLECAINIDE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc": {
      "match": "brand_token",
      "title": "FLECAINIDE ACETATE TABLET [EPIC PHARMA, LLC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72789-385_4bc04d15-e3ce-d29c-e063-6294a90a0103",
  "productndc": "72789-385",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210683",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Sep 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Sep 16, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLECAINIDE ACETATE",
  "proprietary_name": "Flecainide Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210683",
  "marketing_category": "ANDA",
  "nonproprietary_name": "flecainide acetate",
  "start_marketing_date": "20240111",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C01BC04.

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