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United States · US · US:69238-1534_64167760-d963-439f-ac85-21eefb5e8b39

Fluocinonide Cream

Orange BookUNIISPLATC C05AA11

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

Identification

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

Packs · 4

  • ndc11
    6923815342
    1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE
  • ndc11
    6923815343
    1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE
  • ndc11
    6923815345
    1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE
  • ndc11
    6923815346
    1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
2W4A77YPAN
FLUOCINONIDE
RxCUI 4462
Orange Book
A210554
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": "69238-1534_64167760-d963-439f-ac85-21eefb5e8b39",
  "productndc": "69238-1534",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "210554",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Aug 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINONIDE",
  "proprietary_name": "Fluocinonide Cream",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA210554",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluocinonide",
  "start_marketing_date": "20171001",
  "active_numerator_strength": ".5"
}

Related drugs

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