Pramosone

{
  "unii": {
    "unii": "3X7931PO74",
    "rxcui": "27197",
    "inchikey": "ALEXXDVDDISNDU-JZYPGELDSA-N",
    "display_name": "HYDROCORTISONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "b955de80-3bb5-11e5-ac7f-0002a5d5c51b": {
      "match": "brand_token",
      "title": "PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]",
      "spl_version": "15",
      "published_date": "2026-06-01"
    }
  },
  "productid": "83107-021_3726846b-fa95-09cb-e063-6294a90a7bf7",
  "productndc": "83107-021",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "085979",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5%;1%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
  "proprietary_name": "Pramosone",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA085979",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone acetate and pramoxine hydrochloride",
  "start_marketing_date": "20250527",
  "active_numerator_strength": "25; 10"
}