Esmolol Hydrochloride

Orange BookUNIISPLATC C07AB09

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

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeC07AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456745010
10 BAG in 1 CARTON (44567-450-10) / 250 mL in 1 BAG (44567-450-01)

Annotations

UNII (FDA Substance ID)

V05260LC8D

ESMOLOL HYDROCHLORIDE

RxCUI 203222

Orange Book

A214172

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "V05260LC8D",
    "rxcui": "203222",
    "inchikey": "GEKNCWBANDDJJL-UHFFFAOYSA-N",
    "display_name": "ESMOLOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f0a56c07-8f0f-4499-8d00-f13a966bf988": {
      "match": "brand_token",
      "title": "ESMOLOL HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "44567-450_2ee062ee-e28c-4bd7-96b3-e02e3e425d8f",
  "productndc": "44567-450",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "214172",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/100ML",
        "product_no": "001",
        "approval_date": "Dec 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/100ML",
        "product_no": "002",
        "approval_date": "Dec 2, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESMOLOL HYDROCHLORIDE",
  "proprietary_name": "Esmolol Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214172",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esmolol Hydrochloride in Sodium Chloride",
  "start_marketing_date": "20221207",
  "active_numerator_strength": "10"
}

Related drugs

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