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United States · US · US:83107-018_38578221-05d3-cc41-e063-6394a90ac88d

Analpram HC

Orange BookUNIISPLATC D07AB

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

Identification

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

Packs · 1

  • ndc11
    8310701801
    28.4 g in 1 TUBE, WITH APPLICATOR (83107-018-01)

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": {
    "3e5c6728-ece3-40f7-9e36-cff71f168cd8": {
      "match": "brand_token",
      "title": "ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [LEGACY PHARMA USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-26"
    }
  },
  "productid": "83107-018_38578221-05d3-cc41-e063-6394a90ac88d",
  "productndc": "83107-018",
  "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": "Analpram HC",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA085368",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone acetate and pramoxine hydrochloride",
  "start_marketing_date": "20250623",
  "active_numerator_strength": "10; 10"
}

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