FDA.reportPublic FDA data

Arnuity Ellipta

Product NDC
0173-0888
11-digit product format
001730888
Labeler code
0173
Product ID
0173-0888_99087493-3503-425e-91e3-ba430d16104f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA205625
Marketing category
NDA
Marketing start
2018-05-17
Substance
FLUTICASONE FUROATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arnuity Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJS86977WNV
Rxcui1547658, 1547660, 1547663, 1547664, 1547666, 1547668, 1547671, 1547672, 2045377, 2045382

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
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
0173-0888-10Arnuity Ellipta30 in 1 INHALERPOWDER3017
0173-0888-10Arnuity Ellipta1 in 1 CARTONPOWDER117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0888-10EA - Each0173-088891a17440-98aa-40ba-93f0-a5ea7779c77112018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE FUROATEACTIVE INGREDIENTJS86977WNVARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4
FLUTICASONEACTIVE MOIETYCUT2W21N7UARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0888ARNUITY ELLIPTA (FLUTICASONE FUROATE) POWDER [GLAXOSMITHKLINE LLC]16Current NDC, Legacy NDC, 2 package rows20240308_50f193ee-1691-486d-9370-a664df63695c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547664ARNUITY ELLIPTA 100 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547660ARNUITY ELLIPTA 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547668ARNUITY ELLIPTA 200 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547672ARNUITY ELLIPTA 200 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
2045382Arnuity Ellipta 50 MCG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547663fluticasone furoate 100 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547658fluticasone furoate 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547666fluticasone furoate 200 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
1547671fluticasone furoate 200 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN50f193ee-1691-486d-9370-a664df63695c17
154766414 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766814 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
204538230 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766030 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154767230 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder Inhaler [Arnuity]SBD50f193ee-1691-486d-9370-a664df63695c17
154766314 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154766614 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
204537730 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154765830 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154767130 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder InhalerSCD50f193ee-1691-486d-9370-a664df63695c17
154766814 ACTUAT Arnuity 0.2 MG/ACTUAT Dry Powder InhalerSY50f193ee-1691-486d-9370-a664df63695c17
204538230 ACTUAT Arnuity 0.05 MG/ACTUAT Dry Powder InhalerSY50f193ee-1691-486d-9370-a664df63695c17
1547664Arnuity 0.1 MG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547660Arnuity 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersSY50f193ee-1691-486d-9370-a664df63695c17
1547664Arnuity Ellipta 100 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547672Arnuity Ellipta 200 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547663fluticasone furoate 100 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547658fluticasone furoate 100 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547666fluticasone furoate 200 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
1547671fluticasone furoate 200 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSY50f193ee-1691-486d-9370-a664df63695c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0888-10001730888101 INHALER in 1 CARTON (0173-0888-10) / 30 POWDER in 1 INHALER1 inhaler2018-05-170000-00-00NoNoCurrent
0173-0888-62001730888621 INHALER in 1 CARTON (0173-0888-62) > 30 POWDER in 1 INHALER1 inhaler2018-05-170000-00-00NoNoCurrent