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United States · US · US:0173-0874_99087493-3503-425e-91e3-ba430d16104f

Arnuity Ellipta

In shortageOrange BookUNIISPLATC R01AD12

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

Identification

ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeR01AD12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0173087410
    1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER
  • ndc11
    0173087414
    1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)
JS86977WNV
FLUTICASONE FUROATE
RxCUI 705022
Orange Book
N205625
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
  "unii": {
    "unii": "JS86977WNV",
    "rxcui": "705022",
    "inchikey": "XTULMSXFIHGYFS-VLSRWLAYSA-N",
    "display_name": "FLUTICASONE FUROATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "50f193ee-1691-486d-9370-a664df63695c": {
      "match": "brand_token",
      "title": "ARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]",
      "spl_version": "17",
      "published_date": "2025-08-18"
    }
  },
  "productid": "0173-0874_99087493-3503-425e-91e3-ba430d16104f",
  "productndc": "0173-0874",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "205625",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/INH",
        "product_no": "001",
        "approval_date": "Aug 20, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/INH",
        "product_no": "002",
        "approval_date": "Aug 20, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05MG/INH",
        "product_no": "003",
        "approval_date": "May 17, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUTICASONE FUROATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "Arnuity Ellipta",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205625",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluticasone furoate",
  "start_marketing_date": "20140820",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code R01AD12.

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