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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

  • ndc11
    6854711110
    1 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
}

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