NEXTERONE (AMIODARONE HCI)

Orange BookUNIISPLATC C01BD01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeC01BD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166214801
1 BAG in 1 CARTON (51662-1480-1) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

976728SY6Z

AMIODARONE HYDROCHLORIDE

RxCUI 203114

Orange Book

N022325

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": "INTRAVENOUS",
  "spl_meta": {
    "e9108958-b8d7-4fba-87c3-9a32990de551": {
      "match": "brand_token",
      "title": "NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "23",
      "published_date": "2026-04-09"
    }
  },
  "productid": "51662-1480_11c3bf02-6616-9353-e063-6394a90af9cd",
  "productndc": "51662-1480",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022325",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 24, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG/100ML (1.5MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 16, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "360MG/200ML (1.8MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 16, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMIODARONE HYDROCHLORIDE",
  "proprietary_name": "NEXTERONE (AMIODARONE HCI)",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022325",
  "marketing_category": "NDA",
  "nonproprietary_name": "NEXTERONE (AMIODARONE HCI)",
  "start_marketing_date": "20200129",
  "active_numerator_strength": "1.5"
}

Related drugs

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