FDA.reportPublic FDA data

Trelegy Ellipta

Product NDC
0173-0887
11-digit product format
001730887
Labeler code
0173
Product ID
0173-0887_3adf47cb-c3b5-4fdb-9441-d90679b79687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA209482
Marketing category
NDA
Marketing start
2017-09-18
Substance
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active strength
100; 62.5; 25 ug/1; ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [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
Trelegy Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE100 ug/1
UMECLIDINIUM BROMIDE62.5 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40AHO2C6DG, 7AN603V4JV, JS86977WNV
Rxcui1945039, 1945044, 1945047, 1945048, 2395769, 2395771, 2395774, 2395775

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
b8f051f0-c83d-4101-9511-7c3765599726Product name120190910
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
0173-0887-10Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0887-10Trelegy Ellipta1 in 1 TRAYPOWDER114
0173-0887-14Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0887-14Trelegy Ellipta1 in 1 TRAYPOWDER114
0173-0887-61Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0887-61Trelegy Ellipta1 in 1 TRAYPOWDER114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0887-10EA - Each0173-08878f9db8cb-2577-4a4f-948c-7b01cd489bc112017-11-06
0173-0887-14EA - Each0173-0887783540b4-2720-4201-91f6-58da82011d3d12017-11-06
0173-0887-61EA - Each0173-08877c650d41-8501-4ea9-bea6-aaae76441f2912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0887TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]12Current NDC, Legacy NDC, 6 package rows20240302_b5a81d5a-4648-4c7a-951d-33c014a63c7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1945039fluticasone furoate 100 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945047fluticasone furoate 100 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395769fluticasone furoate 200 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395774fluticasone furoate 200 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945044TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945048TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 30 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395771TRELEGY ELLIPTA 200 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395775TRELEGY ELLIPTA 200 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 30 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504414 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577114 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504830 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577530 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194503914 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239576914 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504730 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577430 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945039fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945047fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395769fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395774fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945044Trelegy Ellipta (fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945048Trelegy Ellipta (fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395771Trelegy Ellipta (fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395775Trelegy Ellipta (fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0887-10001730887101 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2017-09-180000-00-00NoNoCurrent
0173-0887-14001730887141 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER1 tray2017-09-180000-00-00NoNoCurrent
0173-0887-61001730887611 TRAY in 1 CARTON (0173-0887-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER1 tray2017-09-180000-00-00YesNoCurrent