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United States · US · US:0143-9979_6341f645-bd5f-4d4f-a532-2c0740ab95f5
Cefuroxime
Orange BookUNIISPLATC J01DC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01DC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014399792225 VIAL in 1 CARTON (0143-9979-22) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9979-90)
Annotations
UNII (FDA Substance ID)
R8A7M9MY61
CEFUROXIME SODIUM
RxCUI 204144
Orange Book
A065048
ABAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R8A7M9MY61",
"rxcui": "204144",
"inchikey": "URDOHUPGIOGTKV-JTBFTWTJSA-M",
"display_name": "CEFUROXIME SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"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": "0143-9979_6341f645-bd5f-4d4f-a532-2c0740ab95f5",
"productndc": "0143-9979",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "065048",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 750MG BASE/VIAL",
"product_no": "001",
"approval_date": "Jan 9, 2004"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1.5GM BASE/VIAL",
"product_no": "002",
"approval_date": "Jan 9, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFUROXIME SODIUM",
"proprietary_name": "Cefuroxime",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065048",
"marketing_category": "ANDA",
"nonproprietary_name": "Cefuroxime",
"start_marketing_date": "20040109",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code J01DC02.
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