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United States · US · US:50090-0781_b58a0509-ff56-4e58-84c9-287e17742abe

Cefuroxime Axetil

Orange BookUNIISPLATC J01DC

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01DC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009007810
    20 TABLET in 1 BOTTLE (50090-0781-0)
  • ndc11
    5009007813
    14 TABLET in 1 BOTTLE (50090-0781-3)

Annotations

UNII (FDA Substance ID)
Z49QDT0J8Z
CEFUROXIME AXETIL
RxCUI 20493
Orange Book
A065308
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Z49QDT0J8Z",
    "rxcui": "20493",
    "inchikey": "KEJCWVGMRLCZQQ-YJBYXUATSA-N",
    "display_name": "CEFUROXIME AXETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "50090-0781_b58a0509-ff56-4e58-84c9-287e17742abe",
  "productndc": "50090-0781",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "065308",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG BASE",
        "product_no": "001",
        "approval_date": "Mar 29, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "002",
        "approval_date": "Mar 29, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "003",
        "approval_date": "Mar 29, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFUROXIME AXETIL",
  "proprietary_name": "Cefuroxime Axetil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065308",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefuroxime Axetil",
  "start_marketing_date": "20060329",
  "active_numerator_strength": "250"
}

Related drugs

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