UREDEX

UNIISPLATC D02AE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBlue Heron Pharmaceuticals, LLC

CountryUS (United States)

ATC codeD02AE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8562260103
85 g in 1 BOTTLE, PLASTIC (85622-601-03)

Annotations

UNII (FDA Substance ID)

8W8T17847W

UREA

RxCUI 11002

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8W8T17847W",
    "rxcui": "11002",
    "inchikey": "XSQUKJJJFZCRTK-UHFFFAOYSA-N",
    "display_name": "UREA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "0e4d7b03-527f-4cff-9154-7e5e485a8f80": {
      "match": "brand_token",
      "title": "UREDEX (UREA) CREAM [BLUE HERON PHARMACEUTICALS, LLC]",
      "spl_version": "2",
      "published_date": "2026-01-19"
    }
  },
  "productid": "85622-601_08af3450-45c1-4a9c-ba34-b2db7d605f5c",
  "productndc": "85622-601",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "UREA",
  "proprietary_name": "UREDEX",
  "active_ingred_unit": "mg/g",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "UREA",
  "start_marketing_date": "20260107",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code D02AE01.

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