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United States · US · US:71656-094_518fd6ee-8b48-28ae-e063-6394a90a1303

Fluocinonide

Orange BookUNIISPLATC C05AA11

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

Identification

ManufacturerSaptalis Pharmaceuticals, LLC.
CountryUS (United States)
ATC codeC05AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7165609420
    20 mL in 1 BOTTLE (71656-094-20)
  • ndc11
    7165609460
    60 mL in 1 BOTTLE (71656-094-60)

Annotations

UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A207554
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": "71656-094_518fd6ee-8b48-28ae-e063-6394a90a1303",
  "productndc": "71656-094",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "207554",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Mar 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINONIDE",
  "proprietary_name": "Fluocinonide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207554",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluocinonide",
  "start_marketing_date": "20260511",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code C05AA11.

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