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United States · US · US:0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720

Anoro Ellipta

Orange BookUNIISPLATC R03BB

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

Identification

ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeR03BB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0173086906
    1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER
  • ndc11
    0173086910
    1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

Annotations

UNII (FDA Substance ID)
7AN603V4JV
UMECLIDINIUM BROMIDE
RxCUI 1487512
Orange Book
N203975
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": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "2dbd0671-c565-40c5-bf0f-e324db26799c": {
      "match": "brand_token",
      "title": "ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]",
      "spl_version": "29",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720",
  "productndc": "0173-0869",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "203975",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH",
        "product_no": "001",
        "approval_date": "Dec 18, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE",
  "proprietary_name": "Anoro Ellipta",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA203975",
  "marketing_category": "NDA",
  "nonproprietary_name": "umeclidinium bromide and vilanterol trifenatate",
  "start_marketing_date": "20140131",
  "active_numerator_strength": "62.5; 25"
}

Related drugs

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