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United States · US · US:0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194f

FLUTICASONE PROPIONATE

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0168033215
    15 g in 1 TUBE (0168-0332-15)
  • ndc11
    0168033230
    30 g in 1 TUBE (0168-0332-30)
  • ndc11
    0168033260
    60 g in 1 TUBE (0168-0332-60)

Annotations

UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A076451
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
  "unii": {
    "unii": "O2GMZ0LF5W",
    "rxcui": "50121",
    "inchikey": "WMWTYOKRWGGJOA-CENSZEJFSA-N",
    "display_name": "FLUTICASONE PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "da4e897e-9be1-499a-8889-15398b30ef3b": {
      "match": "brand_token",
      "title": "FLUTICASONE PROPIONATE DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194f",
  "productndc": "0168-0332",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "076451",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "May 14, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUTICASONE PROPIONATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "FLUTICASONE PROPIONATE",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA076451",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluticasone propionate",
  "start_marketing_date": "20040514",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AC17.

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