AndroGel

{
  "unii": {
    "unii": "3XMK78S47O",
    "rxcui": "10379",
    "inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
    "display_name": "TESTOSTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "f4e8d29b-8707-4d47-e053-2a95a90aecee": {
      "match": "brand_token",
      "title": "ANDROGEL (TESTOSTERONE) GEL [ASCEND THERAPEUTICS U.S., LLC]",
      "spl_version": "130",
      "published_date": "2025-11-17"
    }
  },
  "productid": "17139-562_130cc5ce-2385-4630-a8a1-2767bb1e0575",
  "productndc": "17139-562",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022309",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1.62% (20.25MG/1.25GM ACTUATION)",
        "product_no": "001",
        "approval_date": "Apr 29, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Sep 7, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Sep 7, 2012"
      }
    ],
    "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": "AndroGel",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA022309",
  "marketing_category": "NDA",
  "nonproprietary_name": "Testosterone",
  "start_marketing_date": "20230217",
  "active_numerator_strength": "16.2"
}