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United States · US · US:67457-182_677a4e72-7b0a-4f6c-b82e-091d93588566

Esmolol Hydrochloride

Orange BookUNIISPLATC C07AB09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745718210
    10 VIAL in 1 CARTON (67457-182-10) / 10 mL in 1 VIAL (67457-182-00)

Annotations

UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A076474
AP
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": "67457-182_677a4e72-7b0a-4f6c-b82e-091d93588566",
  "productndc": "67457-182",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076474",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "May 2, 2005"
      }
    ],
    "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": "ANDA076474",
  "marketing_category": "ANDA",
  "nonproprietary_name": "esmolol hydrochloride",
  "start_marketing_date": "20070529",
  "active_numerator_strength": "10"
}

Related drugs

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