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United States · US · US:63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b
Cefuroxime axetil
Orange BookUNIISPLATC J01DC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01DC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11631879912020 TABLET, FILM COATED in 1 BOTTLE (63187-991-20)
- ndc11631879916060 TABLET, FILM COATED in 1 BOTTLE (63187-991-60)
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": "63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b",
"productndc": "63187-991",
"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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