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United States · US · US:67919-030_23d9b7be-abf3-4ca6-bce8-d80643a708e7

ZERBAXA

Orange BookUNIISPLATC J01CG

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ01CG
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6791903001
    10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
7R247U84HY
CEFTOLOZANE SULFATE
RxCUI 1597608
Orange Book
N206829
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7R247U84HY",
    "rxcui": "1597608",
    "inchikey": "UJDQGRLTPBVSFN-TVNHLQOTSA-N",
    "display_name": "CEFTOLOZANE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "70ac1d90-eff3-4f0b-9f46-5846c571b32f": {
      "match": "brand_token",
      "title": "ZERBAXA (CEFTOLOZANE AND TAZOBACTAM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "23",
      "published_date": "2026-05-28"
    }
  },
  "productid": "67919-030_23d9b7be-abf3-4ca6-bce8-d80643a708e7",
  "productndc": "67919-030",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206829",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 19, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM",
  "proprietary_name": "ZERBAXA",
  "active_ingred_unit": "g/10mL; g/10mL",
  "application_number": "NDA206829",
  "marketing_category": "NDA",
  "nonproprietary_name": "ceftolozane and tazobactam",
  "start_marketing_date": "20141219",
  "active_numerator_strength": "1; .5"
}

Related drugs

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