Home NDC 66993-166 Fluticasone Furoate Ellipta
Product NDC 66993-166
11-digit product format 669930166
Labeler code 66993
Product ID 66993-166_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 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205625-001 ARNUITY ELLIPTA FLUTICASONE FUROATE 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 N205625-002 ARNUITY ELLIPTA FLUTICASONE FUROATE 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 N205625-003 ARNUITY ELLIPTA FLUTICASONE FUROATE 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205625-003 M-290 2026-03-01
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205625-002 ARNUITY ELLIPTA 0.2MG/INH POWDER / INHALATION RLD, RS 2014-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205625-003 ARNUITY ELLIPTA 0.05MG/INH POWDER / INHALATION RLD, RS 2018-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205625-001 ARNUITY ELLIPTA 0.1MG/INH POWDER / INHALATION RLD, RS 2014-08-20 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 20 · 780 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 9333310 2027-10-02 Drug product 2016-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 9333310*PED 2028-04-02 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 8201556 2029-02-05 Drug product 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 8746242 2030-10-11 Drug product 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-001 8746242*PED 2031-04-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 9333310 2027-10-02 Drug product 2016-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 9333310*PED 2028-04-02 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 8201556 2029-02-05 Drug product 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 8746242 2030-10-11 Drug product 2014-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-002 8746242*PED 2031-04-11 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 9333310 2027-10-02 Drug product 2018-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 9333310*PED 2028-04-02 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 8201556 2029-02-05 Drug product 2018-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 8746242 2030-10-11 Drug product 2018-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205625-003 8746242*PED 2031-04-11 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 9333310 2027-10-02 Drug product 2016-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 9333310*PED 2028-04-02 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 8201556 2029-02-05 Drug product 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 8746242 2030-10-11 Drug product 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-001 8746242*PED 2031-04-11 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 9333310 2027-10-02 Drug product 2016-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 9333310*PED 2028-04-02 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 8201556 2029-02-05 Drug product 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 8746242 2030-10-11 Drug product 2014-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-002 8746242*PED 2031-04-11 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 9333310 2027-10-02 Drug product 2018-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 9333310*PED 2028-04-02 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 8201556 2029-02-05 Drug product 2018-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 8746242 2030-10-11 Drug product 2018-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205625-003 8746242*PED 2031-04-11 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 9333310 2027-10-02 Drug product 2016-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 9333310*PED 2028-04-02 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 8201556 2029-02-05 Drug product 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 8746242 2030-10-11 Drug product 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-001 8746242*PED 2031-04-11 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 9333310 2027-10-02 Drug product 2016-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 9333310*PED 2028-04-02 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 8201556 2029-02-05 Drug product 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 8746242 2030-10-11 Drug product 2014-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205625-002 8746242*PED 2031-04-11 Pediatric extension 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluticasone Furoate Ellipta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTICASONE FUROATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JS86977WNV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1547658 Internal RxNorm lookup 1547671 Internal RxNorm lookup 2045377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66993-166-97 Fluticasone Furoate Ellipta 30 in 1 INHALER POWDER 30 2 66993-166-97 Fluticasone Furoate Ellipta 1 in 1 CARTON POWDER 1 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66993-166-97 66993016697 1 INHALER in 1 CARTON (66993-166-97) / 30 POWDER in 1 INHALER 1 inhaler 2025-07-21 No No Current