Fluticasone Furoate Ellipta

In shortageOrange BookUNIISPLATC R01AD12

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeR01AD12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699316797
1 INHALER in 1 CARTON (66993-167-97) / 30 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": {
    "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": "66993-167_e2f28ba9-2e90-465a-a6d4-c415c6987b79",
  "productndc": "66993-167",
  "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": "Fluticasone Furoate Ellipta",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205625",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "fluticasone furoate",
  "start_marketing_date": "20250721",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code R01AD12.

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