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United States · US · US:54766-716_431495fb-6225-9c16-e063-6394a90a14ba

Pramosone Cream

Orange BookUNIISPLATC D07AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSebela Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5476671603
    57 g in 1 TUBE (54766-716-03)
  • ndc11
    5476671604
    28.4 g in 1 TUBE (54766-716-04)

Annotations

UNII (FDA Substance ID)
3X7931PO74
HYDROCORTISONE ACETATE
RxCUI 27197
Orange Book
A085368
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "54766-716_431495fb-6225-9c16-e063-6394a90a14ba",
  "productndc": "54766-716",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "085368",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%;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 Cream",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA085368",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone acetate and pramoxine hydrochloride",
  "start_marketing_date": "20150804",
  "active_numerator_strength": "10; 10"
}

Related drugs

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