Testosterone

{
  "unii": {
    "unii": "3XMK78S47O",
    "rxcui": "10379",
    "inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
    "display_name": "TESTOSTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "28e8d504-5073-1d78-f351-bcb7c5188ee6": {
      "match": "brand_token",
      "title": "TESTOSTERONE GEL, METERED [XIROMED, LLC]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66993-953_c9fee58e-0843-4cf3-8d60-c578dc9a288f",
  "productndc": "66993-953",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "021015",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 28, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 28, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Sep 26, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Testosterone",
  "active_ingred_unit": "mg/1.25g",
  "application_number": "NDA021015",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "testosterone",
  "start_marketing_date": "20250519",
  "active_numerator_strength": "12.5"
}