umeclidinium and vilanterol ellipta

Generic: umeclidinium bromide and vilanterol trifenatate

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name umeclidinium and vilanterol ellipta
Generic Name umeclidinium bromide and vilanterol trifenatate
Labeler prasco laboratories
Dosage Form POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

umeclidinium bromide 62.5 ug/1, vilanterol trifenatate 25 ug/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-134
Product ID 66993-134_bffa73f4-99ab-49a2-b585-0982dd611110
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203975
Listing Expiration 2026-12-31
Marketing Start 2025-04-11

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993134
Hyphenated Format 66993-134

Supplemental Identifiers

RxCUI
1487527
UNII
7AN603V4JV 40AHO2C6DG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name umeclidinium and vilanterol ellipta (source: ndc)
Generic Name umeclidinium bromide and vilanterol trifenatate (source: ndc)
Application Number NDA203975 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 62.5 ug/1
  • 25 ug/1
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER
source: ndc

Packages (1)

66993-134-97 1 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

Ingredients (2)

umeclidinium bromide (62.5 ug/1) vilanterol trifenatate (25 ug/1)

Linked Drug Pages (1)

Umeclidinium and Vilanterol Ellipta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "bffa73f4-99ab-49a2-b585-0982dd611110", "openfda": {"unii": ["7AN603V4JV", "40AHO2C6DG"], "rxcui": ["1487527"], "spl_set_id": ["6de414b1-f707-4b98-9e4b-742032ec90af"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (66993-134-97)  / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER", "package_ndc": "66993-134-97", "marketing_start_date": "20250411"}], "brand_name": "Umeclidinium and Vilanterol Ellipta", "product_id": "66993-134_bffa73f4-99ab-49a2-b585-0982dd611110", "dosage_form": "POWDER", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "66993-134", "generic_name": "umeclidinium bromide and vilanterol trifenatate", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Umeclidinium and Vilanterol Ellipta", "active_ingredients": [{"name": "UMECLIDINIUM BROMIDE", "strength": "62.5 ug/1"}, {"name": "VILANTEROL TRIFENATATE", "strength": "25 ug/1"}], "application_number": "NDA203975", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250411", "listing_expiration_date": "20261231"}