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United States · US · US:57483-180_38944633-aed4-4136-ab93-335d250d4e87

FLUTICARE

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerINNOVUS PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5748318011
    1 BOTTLE in 1 CARTON (57483-180-11) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)
  • ndc11
    5748318012
    2 BOTTLE in 1 CARTON (57483-180-12) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)

Annotations

UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A217088
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": {
    "fed545ab-6a85-4ce3-8651-370e279db49e": {
      "match": "brand_token",
      "title": "FLUTICARE (FLUTICASONE PROPIONATE) SPRAY, METERED [INNOVUS PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2025-07-22"
    }
  },
  "productid": "57483-180_38944633-aed4-4136-ab93-335d250d4e87",
  "productndc": "57483-180",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "217088",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "May 10, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FLUTICASONE PROPIONATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "FLUTICARE",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA217088",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluticasone propionate",
  "start_marketing_date": "20250228",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D07AC17.

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