Breo Ellipta

In shortageOrange BookUNIISPLATC D07AC

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlaxoSmithKline LLC

CountryUS (United States)

ATC codeD07AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0173085910
1 TRAY in 1 CARTON (0173-0859-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
ndc11
0173085914
1 TRAY in 1 CARTON (0173-0859-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)

JS86977WNV

FLUTICASONE FUROATE

RxCUI 705022

Orange Book

N204275

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": {
    "96428df1-ea05-431a-98d3-1ec2c4b63878": {
      "match": "brand_token",
      "title": "BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]",
      "spl_version": "28",
      "published_date": "2025-05-21"
    }
  },
  "productid": "0173-0859_03107b41-0bf9-463a-a6e4-956444373e81",
  "productndc": "0173-0859",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "204275",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1MG/INH;EQ 0.025MG BASE/INH",
        "product_no": "001",
        "approval_date": "May 10, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/INH;EQ 0.025MG BASE/INH",
        "product_no": "002",
        "approval_date": "Apr 30, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05MG/INH;EQ 0.025MG BASE/INH",
        "product_no": "003",
        "approval_date": "May 12, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUTICASONE FUROATE; VILANTEROL TRIFENATATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "Breo Ellipta",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA204275",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluticasone furoate and vilanterol trifenatate",
  "start_marketing_date": "20130826",
  "active_numerator_strength": "100; 25"
}

Related drugs

Other records sharing ATC code D07AC.

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