FDA.reportPublic FDA data

Anoro Ellipta

Product NDC
0173-0869
11-digit product format
001730869
Labeler code
0173
Product ID
0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
umeclidinium bromide and vilanterol trifenatate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA203975
Marketing category
NDA
Marketing start
2014-01-31
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
Anoro 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
Rxcui1487519, 1487524, 1487527, 1487528

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
0173-0869-06Anoro Ellipta1 in 1 CARTONPOWDER129
0173-0869-06Anoro Ellipta1 in 1 TRAYPOWDER129
0173-0869-10Anoro Ellipta1 in 1 TRAYPOWDER129
0173-0869-10Anoro Ellipta1 in 1 CARTONPOWDER129
0173-0869-61Anoro Ellipta1 in 1 CARTONPOWDER129
0173-0869-61Anoro Ellipta1 in 1 TRAYPOWDER129

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UMECLIDINIUM BROMIDEACTIVE INGREDIENT7AN603V4JVANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7
VILANTEROL TRIFENATATEACTIVE INGREDIENT40AHO2C6DGANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7
UMECLIDINIUMACTIVE MOIETYGE2T1418SVANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7
VILANTEROLACTIVE MOIETY028LZY775BANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0869ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]28Current NDC, Legacy NDC, 6 package rows20250101_2dbd0671-c565-40c5-bf0f-e324db26799c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487528ANORO Ellipta 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN2dbd0671-c565-40c5-bf0f-e324db26799c29
1487524ANORO Ellipta 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 BlistersPSN2dbd0671-c565-40c5-bf0f-e324db26799c29
1487527umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN2dbd0671-c565-40c5-bf0f-e324db26799c29
1487519umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 BlistersPSN2dbd0671-c565-40c5-bf0f-e324db26799c29
148752830 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Anoro]SBD2dbd0671-c565-40c5-bf0f-e324db26799c29
14875247 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Anoro]SBD2dbd0671-c565-40c5-bf0f-e324db26799c29
148752730 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD2dbd0671-c565-40c5-bf0f-e324db26799c29
14875197 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD2dbd0671-c565-40c5-bf0f-e324db26799c29
1487528Anoro Ellipta (umeclidinium 62.5 MCG / vilanterol 25 MCG) per ACTUAT Dry Powder Inhaler, 30 ACTUATSY2dbd0671-c565-40c5-bf0f-e324db26799c29
1487524Anoro Ellipta (umeclidinium 62.5 MCG / vilanterol 25 MCG) per ACTUAT Dry Powder Inhaler, 7 ACTUATSY2dbd0671-c565-40c5-bf0f-e324db26799c29
1487527umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 30 ACTUAT Dry Powder InhalerSY2dbd0671-c565-40c5-bf0f-e324db26799c29
1487519umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 7 ACTUAT Dry Powder InhalerSY2dbd0671-c565-40c5-bf0f-e324db26799c29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0869-06001730869061 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER1 tray2014-01-310000-00-00NoNoCurrent
0173-0869-10001730869101 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2014-01-310000-00-00NoNoCurrent
0173-0869-61001730869611 TRAY in 1 CARTON (0173-0869-61) > 1 INHALER in 1 TRAY > 7 POWDER in 1 INHALER1 tray2014-01-310000-00-00NoNoCurrent