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United States · US · US:66288-1300_8476cb2d-2615-4637-ab51-363d639a6022

CEFAZOLIN

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerSamson Medical Technologies, L.L.C.
CountryUS (United States)
ATC codeJ01DB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6628813001
    1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG (66288-1300-1)

Annotations

UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
A065141
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": "66288-1300_8476cb2d-2615-4637-ab51-363d639a6022",
  "productndc": "66288-1300",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065141",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 29, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 300GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Nov 29, 2006"
      }
    ],
    "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": "ANDA065141",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEFAZOLIN SODIUM",
  "start_marketing_date": "20070101",
  "active_numerator_strength": "300"
}

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