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United States · US · US:45802-761_9f42e872-a537-4ef0-85f0-7c5e0445a92a

FLUOCINONIDE

Orange BookUNIISPLATC C05AA11

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeC05AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4580276115
    1 TUBE in 1 CARTON (45802-761-15) / 15 g in 1 TUBE
  • ndc11
    4580276130
    1 TUBE in 1 CARTON (45802-761-30) / 30 g in 1 TUBE
  • ndc11
    4580276160
    1 TUBE in 1 CARTON (45802-761-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A209030
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2W4A77YPAN",
    "rxcui": "4462",
    "inchikey": "WJOHZNCJWYWUJD-IUGZLZTKSA-N",
    "display_name": "FLUOCINONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "38a36184-22b4-4e97-83e1-fdd984ef6ccb": {
      "match": "brand_token",
      "title": "FLUOCINONIDE (FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%) SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-20"
    }
  },
  "productid": "45802-761_9f42e872-a537-4ef0-85f0-7c5e0445a92a",
  "productndc": "45802-761",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "209030",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jun 19, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINONIDE",
  "proprietary_name": "FLUOCINONIDE",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA209030",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluocinonide",
  "start_marketing_date": "20250410",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code C05AA11.

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