Amiodarone Hydrochloride

Orange BookUNIISPLATC C01BD01

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

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeC01BD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026809715
50 BLISTER PACK in 1 BOX (50268-097-15) / 1 TABLET in 1 BLISTER PACK (50268-097-11)

Annotations

UNII (FDA Substance ID)

976728SY6Z

AMIODARONE HYDROCHLORIDE

RxCUI 203114

Orange Book

A075389

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "976728SY6Z",
    "rxcui": "203114",
    "inchikey": "ITPDYQOUSLNIHG-UHFFFAOYSA-N",
    "display_name": "AMIODARONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f4532f12-3b7a-42ab-9a6c-36fd2a3f192c": {
      "match": "brand_token",
      "title": "AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-25"
    }
  },
  "productid": "50268-097_47e23673-1380-50b5-e063-6394a90a9314",
  "productndc": "50268-097",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075389",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jan 25, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Dec 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Dec 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMIODARONE HYDROCHLORIDE",
  "proprietary_name": "Amiodarone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075389",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amiodarone Hydrochloride",
  "start_marketing_date": "20190911",
  "active_numerator_strength": "100"
}

Related drugs

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