ADVAIR HFA

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
0173071620
1 INHALER in 1 CARTON (0173-0716-20) / 120 AEROSOL, METERED in 1 INHALER
ndc11
0173071622
1 INHALER in 1 CARTON (0173-0716-22) / 60 AEROSOL, METERED in 1 INHALER

Annotations

UNII (FDA Substance ID)

O2GMZ0LF5W

FLUTICASONE PROPIONATE

RxCUI 50121

Orange Book

N021254

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": {
    "dfaca6f9-3277-47b2-319d-1377917cb54c": {
      "match": "brand_token",
      "title": "ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]",
      "spl_version": "37",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0173-0716_bea52e57-aa75-4dce-8cfb-a163bbc22be2",
  "productndc": "0173-0716",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "021254",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.045MG/INH;EQ 0.021MG BASE/INH",
        "product_no": "001",
        "approval_date": "Jun 8, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.115MG/INH;EQ 0.021MG BASE/INH",
        "product_no": "002",
        "approval_date": "Jun 8, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.23MG/INH;EQ 0.021MG BASE/INH",
        "product_no": "003",
        "approval_date": "Jun 8, 2006"
      }
    ],
    "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": "ADVAIR HFA",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA021254",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluticasone propionate and salmeterol xinafoate",
  "start_marketing_date": "20080929",
  "active_numerator_strength": "115; 21"
}

Related drugs

Other records sharing ATC code D07AC.

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