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United States · US · US:21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3

FLUOCINONIDE

Orange BookUNIISPLATC C05AA11

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

Identification

ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeC05AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    2192206403
    1 TUBE in 1 CARTON (21922-064-03) / 120 g in 1 TUBE
  • ndc11
    2192206404
    1 TUBE in 1 CARTON (21922-064-04) / 15 g in 1 TUBE
  • ndc11
    2192206405
    1 TUBE in 1 CARTON (21922-064-05) / 30 g in 1 TUBE
  • ndc11
    2192206407
    1 TUBE in 1 CARTON (21922-064-07) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A211410
AB1
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": "21922-064_d17e15ec-9150-4fe3-acd1-4573300d9bf3",
  "productndc": "21922-064",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "211410",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Oct 16, 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": "ANDA211410",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluocinonide",
  "start_marketing_date": "20250225",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code C05AA11.

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