Wixela Inhub

In shortageOrange BookUNIISPLATC D07AC

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeD07AC

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378932132
1 INHALER in 1 CARTON (0378-9321-32) / 60 POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)

O2GMZ0LF5W

FLUTICASONE PROPIONATE

RxCUI 50121

Orange Book

A208891

ABABAB

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": {
    "6a5e28ef-3bbb-43a6-b599-499b3c6076c9": {
      "match": "brand_token",
      "title": "WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2025-02-17"
    }
  },
  "productid": "0378-9321_03d33612-03b4-4a2c-ba86-47816db363ce",
  "productndc": "0378-9321",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "208891",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "001",
        "approval_date": "Jan 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "002",
        "approval_date": "Jan 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG/INH;EQ 0.05MG BASE/INH",
        "product_no": "003",
        "approval_date": "Jan 30, 2019"
      }
    ],
    "appl_type": "A"
  },
  "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": "Wixela Inhub",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "ANDA208891",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluticasone propionate and salmeterol",
  "start_marketing_date": "20190211",
  "active_numerator_strength": "250; 50"
}

Related drugs

Other records sharing ATC code D07AC.

Access this data programmatically

Query Wixela Inhub and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs