Cefuroxime axetil

Orange BookUNIISPLATC J01DC

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeJ01DC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787721601
100 TABLET, FILM COATED in 1 BOTTLE (67877-216-01)
ndc11
6787721620
20 TABLET, FILM COATED in 1 BOTTLE (67877-216-20)
ndc11
6787721660
60 TABLET, FILM COATED in 1 BOTTLE (67877-216-60)
ndc11
6787721684
30 BLISTER PACK in 1 CARTON (67877-216-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

Z49QDT0J8Z

CEFUROXIME AXETIL

RxCUI 20493

Orange Book

A065496

ABAB

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": "67877-216_7c9fa966-9491-40a8-a57b-6f60dbf7bb55",
  "productndc": "67877-216",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065496",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jun 7, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jun 7, 2010"
      }
    ],
    "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": "ANDA065496",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefuroxime axetil",
  "start_marketing_date": "20101201",
  "active_numerator_strength": "500"
}

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