Cefotan

{
  "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": {
    "f1510f5e-d001-44e0-accb-27cf79fd4f9a": {
      "match": "brand_token",
      "title": "CEFOTAN (CEFOTETAN) INJECTION, POWDER, FOR SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]",
      "spl_version": "6",
      "published_date": "2024-04-10"
    }
  },
  "productid": "0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55",
  "productndc": "0121-0976",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050588",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 27, 1985"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Dec 27, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Apr 25, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFOTETAN DISODIUM",
  "proprietary_name": "Cefotan",
  "active_ingred_unit": "g/10mL",
  "application_number": "NDA050588",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cefotetan",
  "start_marketing_date": "20240408",
  "active_numerator_strength": "1"
}