Umeclidinium Ellipta

Orange BookUNIISPLATC R03BB07

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

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeR03BB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699318997
1 TRAY in 1 CARTON (66993-189-97) / 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": {
    "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": "66993-189_78029af6-3c01-4be0-8439-ec3c22b4abb7",
  "productndc": "66993-189",
  "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": "Umeclidinium Ellipta",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205382",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "umeclidinium",
  "start_marketing_date": "20260406",
  "active_numerator_strength": "62.5"
}

Related drugs

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