Cefazolin

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeJ01DB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338009606
6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

P380M0454Z

CEFAZOLIN SODIUM

RxCUI 203171

Orange Book

N207131

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P380M0454Z",
    "rxcui": "203171",
    "inchikey": "FLKYBGKDCCEQQM-WYUVZMMLSA-M",
    "display_name": "CEFAZOLIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d91a8d13-99a0-4d87-88dc-71cbd37922b4": {
      "match": "brand_token",
      "title": "CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "17",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0338-0096_9139fd65-24ba-42a9-a084-9d6dd2d1b181",
  "productndc": "0338-0096",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207131",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/100ML (EQ 20MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Aug 7, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/50ML (EQ 20MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3GM BASE/150ML (EQ 20MG BASE/ML)",
        "product_no": "003",
        "approval_date": "May 31, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFAZOLIN SODIUM",
  "proprietary_name": "Cefazolin",
  "active_ingred_unit": "g/150mL",
  "application_number": "NDA207131",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cefazolin Sodium",
  "start_marketing_date": "20240531",
  "active_numerator_strength": "3"
}

Related drugs

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