Cefotetan

Orange BookUNIISPLATC J01DC05

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ01DC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143967110
10 VIAL in 1 CARTON (0143-9671-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)

Annotations

UNII (FDA Substance ID)

48SPP0PA9Q

CEFOTETAN

RxCUI 2187

Orange Book

A091031

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "48SPP0PA9Q",
    "rxcui": "2187",
    "inchikey": "SRZNHPXWXCNNDU-IXOPCIAXSA-N",
    "display_name": "CEFOTETAN",
    "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": "0143-9671_239c7e32-be35-41ea-b466-2e15d3339398",
  "productndc": "0143-9671",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "091031",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Oct 26, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Oct 26, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFOTETAN",
  "proprietary_name": "Cefotetan",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA091031",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefotetan",
  "start_marketing_date": "20111026",
  "active_numerator_strength": "2"
}

Related drugs

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