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United States · US · US:68547-111_2606ce2c-ad3a-4c58-be0d-9a696d366d64
Xacduro
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLa Jolla Pharmaceutical Company
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168547111101 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)
Annotations
Orange Book
N216974
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"c0167aec-a89d-4e96-afe5-2ccf3e89fe72": {
"match": "brand_token",
"title": "XACDURO (SULBACTAM AND DURLOBACTAM) KIT [LA JOLLA PHARMACEUTICAL COMPANY]",
"spl_version": "11",
"published_date": "2025-12-09"
}
},
"productid": "68547-111_2606ce2c-ad3a-4c58-be0d-9a696d366d64",
"productndc": "68547-111",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "216974",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "May 23, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Xacduro",
"active_ingred_unit": null,
"application_number": "NDA216974",
"marketing_category": "NDA",
"nonproprietary_name": "sulbactam and durlobactam",
"start_marketing_date": "20230606",
"active_numerator_strength": null
}Access this data programmatically
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