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United States · US · US:0054-3270_5896404a-ec42-414a-8d70-3a4147636278

Fluticasone Propionate

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054327099
    1 BOTTLE, GLASS in 1 CARTON (0054-3270-99) / 120 SPRAY, METERED in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A076504
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": "NASAL",
  "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": "0054-3270_5896404a-ec42-414a-8d70-3a4147636278",
  "productndc": "0054-3270",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "076504",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "Feb 22, 2006"
      }
    ],
    "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": "ug/1",
  "application_number": "ANDA076504",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluticasone Propionate",
  "start_marketing_date": "20060222",
  "active_numerator_strength": "50"
}

Related drugs

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