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United States · US · US:65862-698_5716a24a-653f-488a-bb44-85abffcbf92c
Cefuroxime Axetil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11658626982020 TABLET in 1 BOTTLE (65862-698-20)
- ndc11658626986060 TABLET in 1 BOTTLE (65862-698-60)
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": "65862-698_5716a24a-653f-488a-bb44-85abffcbf92c",
"productndc": "65862-698",
"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": "125"
}Related drugs
Other records sharing ATC code J01DC.
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