Umeclidinium and Vilanterol Ellipta

Orange BookUNIISPLATC R03BB

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeR03BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699313497
1 TRAY in 1 CARTON (66993-134-97) / 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": {
    "763388a5-cc89-4c25-8562-521df679b7e8": {
      "match": "brand_token",
      "title": "UMECLIDINIUM ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [PRASCO LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-04-08"
    }
  },
  "productid": "66993-134_bffa73f4-99ab-49a2-b585-0982dd611110",
  "productndc": "66993-134",
  "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": "Umeclidinium and Vilanterol Ellipta",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA203975",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "umeclidinium bromide and vilanterol trifenatate",
  "start_marketing_date": "20250411",
  "active_numerator_strength": "62.5; 25"
}

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