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United States · US · US:43063-657_4139efd1-921a-b349-e063-6394a90a0404
Cefuroxime axetil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11430636572020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-20)
- ndc11430636576060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-60)
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": "43063-657_4139efd1-921a-b349-e063-6394a90a0404",
"productndc": "43063-657",
"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": "250"
}Related drugs
Other records sharing ATC code J01DC.
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