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United States · US · US:70518-4410_3b14985c-f435-be98-e063-6294a90a0f92

Esmolol Hydrochloride

Orange BookUNIISPLATC C07AB09

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC07AB09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051844100
    25 VIAL, SINGLE-DOSE in 1 CARTON (70518-4410-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4410-1)

Annotations

UNII (FDA Substance ID)
V05260LC8D
ESMOLOL HYDROCHLORIDE
RxCUI 203222
Orange Book
A205520
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": "70518-4410_3b14985c-f435-be98-e063-6294a90a0f92",
  "productndc": "70518-4410",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205520",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jul 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESMOLOL HYDROCHLORIDE",
  "proprietary_name": "Esmolol Hydrochloride",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA205520",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esmolol Hydrochloride",
  "start_marketing_date": "20250729",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code C07AB09.

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