Cefazolin

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeJ01DB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6718410012
25 VIAL in 1 CARTON (67184-1001-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)

P380M0454Z

CEFAZOLIN SODIUM

RxCUI 203171

Orange Book

A203661

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": "INTRAMUSCULAR; 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": "67184-1001_0cc53b72-80e0-4a82-e063-6394a90a7fdf",
  "productndc": "67184-1001",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "203661",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Mar 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 3GM BASE/VIAL",
        "product_no": "003",
        "approval_date": "Jan 24, 2024"
      }
    ],
    "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": "ANDA203661",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefazolin",
  "start_marketing_date": "20151228",
  "active_numerator_strength": "1"
}

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