Cefuroxime Axetil

Orange BookUNIISPLATC J01DC

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ01DC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807138994
14 TABLET, FILM COATED in 1 BOTTLE (68071-3899-4)

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": "68071-3899_3f92c452-18b5-5af8-e063-6394a90aaa53",
  "productndc": "68071-3899",
  "dosage_form": "TABLET, FILM COATED",
  "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": "500"
}

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