Flecainide Acetate

Orange BookUNIISPLATC C01BC04

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

Identification

ManufacturerUNICHEM PHARMACEUTICALS (USA), INC.

CountryUS (United States)

ATC codeC01BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7638514601
100 TABLET in 1 BOTTLE (76385-146-01)
ndc11
7638514660
60 TABLET in 1 BOTTLE (76385-146-60)

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": "76385-146_6e5f6cbe-c7eb-4168-b02b-119798e895d6",
  "productndc": "76385-146",
  "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": "100"
}

Related drugs

Other records sharing ATC code C01BC04.

Access this data programmatically

Query Flecainide Acetate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs