Cefotetan

Orange BookUNIISPLATC J01DC05

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeJ01DC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332338620
10 VIAL in 1 CARTON (63323-386-20) / 20 mL in 1 VIAL (63323-386-01)

Annotations

UNII (FDA Substance ID)

0GXP746VXB

CEFOTETAN DISODIUM

RxCUI 203141

Orange Book

A065374

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0GXP746VXB",
    "rxcui": "203141",
    "inchikey": "ZQQALMSFFARWPK-GLHLDKNHSA-L",
    "display_name": "CEFOTETAN DISODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e": {
      "match": "brand_token",
      "title": "CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "9",
      "published_date": "2025-01-16"
    }
  },
  "productid": "63323-386_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8",
  "productndc": "63323-386",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065374",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 9, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Aug 9, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFOTETAN DISODIUM",
  "proprietary_name": "Cefotetan",
  "active_ingred_unit": "g/20mL",
  "application_number": "ANDA065374",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEFOTETAN DISODIUM",
  "start_marketing_date": "20091118",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code J01DC05.

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