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United States · US · US:85212-0038_3515b12e-5c2f-2e7c-e063-6394a90aa636

Arthcal ESTROGEN

Orange BookUNIISPLATC G03CA04

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

Identification

ManufacturerBeijing JUNGE Technology Co., Ltd.
CountryUS (United States)
ATC codeG03CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8521200381
    1 mL in 1 BOX (85212-0038-1)

Annotations

UNII (FDA Substance ID)
FB33469R8E
ESTRIOL
RxCUI 4094
Orange Book
A075357
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FB33469R8E",
    "rxcui": "4094",
    "inchikey": "PROQIPRRNZUXQM-ZXXIGWHRSA-N",
    "display_name": "ESTRIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "CUTANEOUS",
  "spl_meta": {
    "3c77f787-b7dd-6813-e063-6394a90aa004": {
      "match": "brand_token",
      "title": "ARTHCAL BIOIDENTICAL PEACH CREAM CREAM [BEIJING JUNGE TECHNOLOGY CO., LTD.]",
      "spl_version": "1",
      "published_date": "2025-08-19"
    }
  },
  "productid": "85212-0038_3515b12e-5c2f-2e7c-e063-6394a90aa636",
  "productndc": "85212-0038",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "075357",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Jul 30, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Jul 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ESTRIOL",
  "proprietary_name": "Arthcal ESTROGEN",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA075357",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESTROGEN",
  "start_marketing_date": "20250101",
  "active_numerator_strength": ".2"
}

Related drugs

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