Fluticasone Propionate and Salmeterol

In shortageOrange BookUNIISPLATC D07AC

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeD07AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009033870
1 POUCH in 1 CARTON (50090-3387-0) / 1 POWDER, METERED in 1 POUCH

Annotations

UNII (FDA Substance ID)

O2GMZ0LF5W

FLUTICASONE PROPIONATE

RxCUI 50121

Orange Book

N208799

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": "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": "50090-3387_4bf35a9c-39b0-4293-a1ae-5a1d1bc97c48",
  "productndc": "50090-3387",
  "dosage_form": "POWDER, METERED",
  "orange_book": {
    "appl_no": "208799",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.055MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "001",
        "approval_date": "Jan 27, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.113MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "002",
        "approval_date": "Jan 27, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.232MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "003",
        "approval_date": "Jan 27, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.055MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "004",
        "approval_date": "Jul 12, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.113MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "005",
        "approval_date": "Jul 12, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.232MG/INH;EQ 0.014MG BASE/INH",
        "product_no": "006",
        "approval_date": "Jul 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "Fluticasone Propionate and Salmeterol",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA208799",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Fluticasone Propionate and Salmeterol",
  "start_marketing_date": "20170428",
  "active_numerator_strength": "232; 14"
}

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