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United States · US · US:63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97

Esmolol Hydrochloride

Orange BookUNIISPLATC C07AB09

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC07AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332366114
    25 VIAL, SINGLE-DOSE in 1 TRAY (63323-661-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-661-04)

Annotations

UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A076573
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": "63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97",
  "productndc": "63323-661",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076573",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "May 2, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "002",
        "approval_date": "Aug 23, 2023"
      }
    ],
    "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": "ANDA076573",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESMOLOL HYDROCHLORIDE",
  "start_marketing_date": "20041130",
  "active_numerator_strength": "10"
}

Related drugs

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