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United States · US · US:44567-811_0aee9e81-c563-4207-9157-8bf70a163010

Esmolol Hydrochloride in Water

Orange BookUNIISPLATC C07AB09

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

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
    4456781110
    10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
N205703
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": "44567-811_0aee9e81-c563-4207-9157-8bf70a163010",
  "productndc": "44567-811",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "205703",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.5GM/250ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 7, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2GM/100ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 7, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESMOLOL HYDROCHLORIDE",
  "proprietary_name": "Esmolol Hydrochloride in Water",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA205703",
  "marketing_category": "NDA",
  "nonproprietary_name": "Esmolol Hydrochloride",
  "start_marketing_date": "20171204",
  "active_numerator_strength": "10"
}

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