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United States · US · US:0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415f

Incruse Ellipta

Orange BookUNIISPLATC R03BB07

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

Identification

ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeR03BB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0173087306
    1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER
  • ndc11
    0173087310
    1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)
7AN603V4JV
UMECLIDINIUM BROMIDE
RxCUI 1487512
Orange Book
N205382
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AN603V4JV",
    "rxcui": "1487512",
    "inchikey": "PEJHHXHHNGORMP-UHFFFAOYSA-M",
    "display_name": "UMECLIDINIUM BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dbb64747-1505-49d7-9a33-99dd402e96d3": {
      "match": "brand_token",
      "title": "INCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]",
      "spl_version": "27",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415f",
  "productndc": "0173-0873",
  "dosage_form": "AEROSOL, POWDER",
  "orange_book": {
    "appl_no": "205382",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.0625MG BASE/INH",
        "product_no": "001",
        "approval_date": "Apr 30, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "UMECLIDINIUM BROMIDE",
  "proprietary_name": "Incruse Ellipta",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205382",
  "marketing_category": "NDA",
  "nonproprietary_name": "umeclidinium",
  "start_marketing_date": "20140430",
  "active_numerator_strength": "62.5"
}

Related drugs

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