Amiodarone Hydrochloride

Orange BookUNIISPLATC C01BD01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC01BD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6586273201
100 TABLET in 1 BOTTLE (65862-732-01)
ndc11
6586273205
500 TABLET in 1 BOTTLE (65862-732-05)
ndc11
6586273225
250 TABLET in 1 BOTTLE (65862-732-25)
ndc11
6586273230
30 TABLET in 1 BOTTLE (65862-732-30)
ndc11
6586273260
60 TABLET in 1 BOTTLE (65862-732-60)
ndc11
6586273290
90 TABLET in 1 BOTTLE (65862-732-90)
ndc11
6586273299
1000 TABLET in 1 BOTTLE (65862-732-99)

Annotations

UNII (FDA Substance ID)

976728SY6Z

AMIODARONE HYDROCHLORIDE

RxCUI 203114

Orange Book

A204742

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": "65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366",
  "productndc": "65862-732",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204742",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jun 3, 2016"
      }
    ],
    "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": "ANDA204742",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amiodarone Hydrochloride",
  "start_marketing_date": "20160603",
  "active_numerator_strength": "200"
}

Related drugs

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