ZEVTERA

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
6854757810
10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01)

Annotations

UNII (FDA Substance ID)

N99027V28J

CEFTOBIPROLE MEDOCARIL SODIUM

Orange Book

N218275

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N99027V28J",
    "rxcui": null,
    "inchikey": "MFAWUGGPPMTWPU-LCJFHXTKSA-M",
    "display_name": "CEFTOBIPROLE MEDOCARIL SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2bd685df-7dc6-78a6-e063-6294a90a580b": {
      "match": "brand_token",
      "title": "ZEVTERA (CEFTOBIPROLE MEDOCARIL SODIUM) INJECTION, POWDER, FOR SOLUTION [LA JOLLA PHARMACEUTICAL COMPANY]",
      "spl_version": "4",
      "published_date": "2025-12-23"
    }
  },
  "productid": "68547-578_b1d1d7ef-5f90-4e2e-b4cf-494815d8647c",
  "productndc": "68547-578",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "218275",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "667MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 3, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTOBIPROLE MEDOCARIL SODIUM",
  "proprietary_name": "ZEVTERA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218275",
  "marketing_category": "NDA",
  "nonproprietary_name": "ceftobiprole medocaril sodium",
  "start_marketing_date": "20250401",
  "active_numerator_strength": "667"
}

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