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United States · US · US:66993-136_18928e94-a9ff-44a6-a65e-c6f8c21c815c

Fluticasone Furoate and Vilanterol

In shortageOrange BookUNIISPLATC D07AC

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

Identification

ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeD07AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6699313697
    1 TRAY in 1 CARTON (66993-136-97) / 1 INHALER in 1 TRAY / 30 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": {
    "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": "66993-136_18928e94-a9ff-44a6-a65e-c6f8c21c815c",
  "productndc": "66993-136",
  "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": "Fluticasone Furoate and Vilanterol",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA204275",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "fluticasone furoate and vilanterol",
  "start_marketing_date": "20220523",
  "active_numerator_strength": "200; 25"
}

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