FDA.reportPublic FDA data

Fluticasone Furoate Ellipta

Product NDC
66993-168
11-digit product format
669930168
Labeler code
66993
Product ID
66993-168_e2f28ba9-2e90-465a-a6d4-c415c6987b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Prasco Laboratories
Application
NDA205625
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-07-21
Substance
FLUTICASONE FUROATE
Active strength
200 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
Fluticasone Furoate Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJS86977WNV
Rxcui1547658, 1547671, 2045377

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
66993-168-97Fluticasone Furoate Ellipta30 in 1 INHALERPOWDER302
66993-168-97Fluticasone Furoate Ellipta1 in 1 CARTONPOWDER12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-168-97EA - Each66993-1687eaef717-6a89-4b9c-9505-c420dfc0834212025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547658fluticasone furoate 100 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSNd3e797fc-2636-49a0-b89e-5246b18ee4402
1547671fluticasone furoate 200 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSNd3e797fc-2636-49a0-b89e-5246b18ee4402
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 BlistersPSNd3e797fc-2636-49a0-b89e-5246b18ee4402
204537730 ACTUAT fluticasone furoate 0.05 MG/ACTUAT Dry Powder InhalerSCDd3e797fc-2636-49a0-b89e-5246b18ee4402
154765830 ACTUAT fluticasone furoate 0.1 MG/ACTUAT Dry Powder InhalerSCDd3e797fc-2636-49a0-b89e-5246b18ee4402
154767130 ACTUAT fluticasone furoate 0.2 MG/ACTUAT Dry Powder InhalerSCDd3e797fc-2636-49a0-b89e-5246b18ee4402
1547658fluticasone furoate 100 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYd3e797fc-2636-49a0-b89e-5246b18ee4402
1547671fluticasone furoate 200 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYd3e797fc-2636-49a0-b89e-5246b18ee4402
2045377fluticasone furoate 50 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYd3e797fc-2636-49a0-b89e-5246b18ee4402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-168-97669930168971 INHALER in 1 CARTON (66993-168-97) / 30 POWDER in 1 INHALER1 inhaler2025-07-21NoNoCurrent