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United States · US · US:45802-928_a5be325d-6006-40c1-bace-5adcf29548e5

Flurandrenolide

Orange BookUNIIATC D07AC07

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD07AC07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4580292803
    120 mL in 1 BOTTLE, PLASTIC (45802-928-03)

Annotations

UNII (FDA Substance ID)
8EUL29XUQT
FLURANDRENOLIDE
RxCUI 4500
Orange Book
A207133
Raw payload (JSON)
{
  "unii": {
    "unii": "8EUL29XUQT",
    "rxcui": "4500",
    "inchikey": "POPFMWWJOGLOIF-XWCQMRHXSA-N",
    "display_name": "FLURANDRENOLIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "productid": "45802-928_a5be325d-6006-40c1-bace-5adcf29548e5",
  "productndc": "45802-928",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "207133",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Aug 30, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLURANDRENOLIDE",
  "proprietary_name": "Flurandrenolide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207133",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flurandrenolide",
  "start_marketing_date": "20161006",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AC07.

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