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United States · US · US:70710-1284_bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962

Fluocinonide

Orange BookUNIISPLATC C05AA11

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC05AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7071012843
    60 mL in 1 BOTTLE (70710-1284-3)
  • ndc11
    7071012848
    20 mL in 1 BOTTLE (70710-1284-8)

Annotations

UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A208948
AT
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": "70710-1284_bd0eaa0d-0a5b-48a2-bc7e-78b8bde33962",
  "productndc": "70710-1284",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208948",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jul 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINONIDE",
  "proprietary_name": "Fluocinonide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA208948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluocinonide",
  "start_marketing_date": "20181101",
  "active_numerator_strength": ".5"
}

Related drugs

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