FDA.reportPublic FDA data

Umeclidinium and Vilanterol Ellipta

Product NDC
66993-134
11-digit product format
669930134
Labeler code
66993
Product ID
66993-134_bffa73f4-99ab-49a2-b585-0982dd611110
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
umeclidinium bromide and vilanterol trifenatate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Prasco Laboratories
Application
NDA203975
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-04-11
Substance
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active strength
62.5; 25 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umeclidinium and Vilanterol Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UMECLIDINIUM BROMIDE62.5 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AN603V4JV, 40AHO2C6DG
Rxcui1487527

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
b8f051f0-c83d-4101-9511-7c3765599726Product name120190910
c982201d-72cb-462f-9e02-902ec0d4a295Product name120181030
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-134-97Umeclidinium and Vilanterol Ellipta1 in 1 TRAYPOWDER13
66993-134-97Umeclidinium and Vilanterol Ellipta1 in 1 CARTONPOWDER13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-134-97EA - Each66993-134fb93907c-6060-465b-92e7-82cea1fa40a212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-134UMECLIDINIUM AND VILLANTEROL ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [PRASCO LABORATORIES]1Current NDC, 2 package rows20250416_6de414b1-f707-4b98-9e4b-742032ec90af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487527umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN6de414b1-f707-4b98-9e4b-742032ec90af3
148752730 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD6de414b1-f707-4b98-9e4b-742032ec90af3
1487527umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 30 ACTUAT Dry Powder InhalerSY6de414b1-f707-4b98-9e4b-742032ec90af3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-134-97669930134971 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2025-04-11NoNoCurrent