Flecainide Acetate

Orange BookUNIISPLATC C01BC04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC01BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6362979791
30 TABLET in 1 BOTTLE (63629-7979-1)
ndc11
6362979792
60 TABLET in 1 BOTTLE (63629-7979-2)
ndc11
6362979793
90 TABLET in 1 BOTTLE (63629-7979-3)
ndc11
6362979794
10 TABLET in 1 BOTTLE (63629-7979-4)
ndc11
6362979795
180 TABLET in 1 BOTTLE (63629-7979-5)

Annotations

UNII (FDA Substance ID)

M8U465Q1WQ

FLECAINIDE ACETATE

RxCUI 42686

Orange Book

A202821

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": "63629-7979_3d65643b-e585-4e81-8792-9089e0fbabd6",
  "productndc": "63629-7979",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202821",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Nov 3, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Nov 3, 2017"
      }
    ],
    "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": "ANDA202821",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flecainide Acetate",
  "start_marketing_date": "20150708",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C01BC04.

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