Cefazolin Sodium

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeJ01DB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0264310511
24 CONTAINER in 1 CASE (0264-3105-11) / 50 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

P380M0454Z

CEFAZOLIN SODIUM

RxCUI 203171

Orange Book

N050779

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": "0264-3105_fb2f076a-22b3-46e0-86c8-7678e89c9edf",
  "productndc": "0264-3105",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "050779",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 27, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 27, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jan 13, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Aug 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFAZOLIN SODIUM",
  "proprietary_name": "Cefazolin Sodium",
  "active_ingred_unit": "g/50mL",
  "application_number": "NDA050779",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cefazolin Sodium",
  "start_marketing_date": "20120113",
  "active_numerator_strength": "2"
}

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