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United States · US · US:0264-3114_6874a295-7ec7-4822-9d04-4dd9932b4546

Cefuroxime and Dextrose

Orange BookUNIISPLATC J01DC02

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeJ01DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264311411
    24 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
R8A7M9MY61
CEFUROXIME SODIUM
RxCUI 204144
Orange Book
N050780
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R8A7M9MY61",
    "rxcui": "204144",
    "inchikey": "URDOHUPGIOGTKV-JTBFTWTJSA-M",
    "display_name": "CEFUROXIME SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d14d4184-3e29-43cd-8046-658699c70f03": {
      "match": "brand_token",
      "title": "CEFUROXIME AXETIL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "3",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0264-3114_6874a295-7ec7-4822-9d04-4dd9932b4546",
  "productndc": "0264-3114",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "050780",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Feb 21, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Feb 21, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFUROXIME SODIUM",
  "proprietary_name": "Cefuroxime and Dextrose",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA050780",
  "marketing_category": "NDA",
  "nonproprietary_name": "CEFUROXIME AND DEXTROSE",
  "start_marketing_date": "20010221",
  "active_numerator_strength": "1.5"
}

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