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United States · US · US:25021-118_da170a9c-def7-432b-8999-701e7b878fe8

Cefuroxime sodium

Orange BookUNIISPLATC J01DC02

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ01DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2502111810
    25 VIAL in 1 CARTON (25021-118-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
R8A7M9MY61
CEFUROXIME SODIUM
RxCUI 204144
Orange Book
A064125
ABAP
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": "INTRAMUSCULAR; 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": "25021-118_da170a9c-def7-432b-8999-701e7b878fe8",
  "productndc": "25021-118",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "064125",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 750MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.5GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "May 30, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFUROXIME SODIUM",
  "proprietary_name": "Cefuroxime sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA064125",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefuroxime sodium",
  "start_marketing_date": "20160901",
  "active_numerator_strength": "750"
}

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