FDA.reportPublic FDA data

Breo Ellipta

Product NDC
0173-0916
11-digit product format
001730916
Labeler code
0173
Product ID
0173-0916_03107b41-0bf9-463a-a6e4-956444373e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate and vilanterol trifenatate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA204275
Marketing category
NDA
Marketing start
2023-05-12
Substance
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Active strength
50; 25 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
Breo Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE50 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJS86977WNV, 40AHO2C6DG
Rxcui1424889, 1424899, 1539891, 1539893, 1648783, 1648785, 1648788, 1648789, 2637473, 2637476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
c982201d-72cb-462f-9e02-902ec0d4a295Product name120181030
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0916-10Breo Ellipta1 in 1 TRAYPOWDER128
0173-0916-10Breo Ellipta1 in 1 CARTONPOWDER128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0916BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]28Current NDC, 2 package rows20250521_96428df1-ea05-431a-98d3-1ec2c4b63878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539891Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
2637476Breo Ellipta 50/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
2637473fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1424899fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1424889fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648783fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
153989114 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878514 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
263747630 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
153989330 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878930 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
142489914 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878314 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
263747330 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
142488930 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878830 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
2637476Breo Ellipta (fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta Institutional PackSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
2637473fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersSY96428df1-ea05-431a-98d3-1ec2c4b6387828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0173-0916-10001730916101 TRAY in 1 CARTON (0173-0916-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2023-05-12NoNoCurrent