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United States · US · US:83107-019_4dcbb97c-b493-022f-e063-6294a90ac089

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 · 2

  • ndc11
    8310701912
    12 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-12) / 4 g in 1 TUBE, WITH APPLICATOR
  • ndc11
    8310701930
    30 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-30) / 4 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
3X7931PO74
HYDROCORTISONE ACETATE
RxCUI 27197
Orange Book
A085979
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": "83107-019_4dcbb97c-b493-022f-e063-6294a90ac089",
  "productndc": "83107-019",
  "dosage_form": "CREAM",
  "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": "Analpram HC",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA085979",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone acetate and pramoxine hydrochloride",
  "start_marketing_date": "20250725",
  "active_numerator_strength": "25; 10"
}

Related drugs

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