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United States · US · US:72189-584_22dfc2e4-07a8-8d13-e063-6394a90a3e9f

Cefazolin Sodium

Orange BookUNIISPLATC J01DB

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

Identification

ManufacturerDirect_rx
CountryUS (United States)
ATC codeJ01DB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218958401
    1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (72189-584-01)

Annotations

UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
A203661
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": "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": "72189-584_22dfc2e4-07a8-8d13-e063-6394a90a3e9f",
  "productndc": "72189-584",
  "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 Sodium",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA203661",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefazolin Sodium",
  "start_marketing_date": "20240924",
  "active_numerator_strength": "1"
}

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