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United States · US · US:44567-708_d94c6e64-269c-4cbb-b5e5-77a338d8c7f3

Cefazolin

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeJ01DB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4456770810
    10 VIAL in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
A065306
AP
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": "44567-708_d94c6e64-269c-4cbb-b5e5-77a338d8c7f3",
  "productndc": "44567-708",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065306",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 22, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Aug 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFAZOLIN SODIUM",
  "proprietary_name": "Cefazolin",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA065306",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefazolin",
  "start_marketing_date": "20150306",
  "active_numerator_strength": "10"
}

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