Brevibloc

Orange BookUNIISPLATC C07AB09

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

Identification

ManufacturerHenry Schein, Inc

CountryUS (United States)

ATC codeC07AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0404982510
1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

V05260LC8D

ESMOLOL HYDROCHLORIDE

RxCUI 203222

Orange Book

N019386

APAPAP

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": {
    "595cc3d5-1306-4828-aefa-5595219ffd62": {
      "match": "brand_token",
      "title": "BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "29",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0404-9825_a2e6fea4-a597-45d7-b157-0b67c924f1bf",
  "productndc": "0404-9825",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019386",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "003",
        "approval_date": "Aug 15, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/100ML",
        "product_no": "004",
        "approval_date": "Feb 16, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2GM/100ML",
        "product_no": "005",
        "approval_date": "Jan 27, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "006",
        "approval_date": "Feb 25, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "007",
        "approval_date": "May 28, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESMOLOL HYDROCHLORIDE",
  "proprietary_name": "Brevibloc",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019386",
  "marketing_category": "NDA",
  "nonproprietary_name": "esmolol hydrochloride",
  "start_marketing_date": "20220109",
  "active_numerator_strength": "10"
}

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