Breo Ellipta

Product NDC: 0173-0916
11-digit product format: 001730916
Labeler code: 0173
Product ID: 0173-0916_10ccfa0a-0453-41bd-b092-d62863a82c26
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N204275-001	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10
N204275-002	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30
N204275-003	BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06
N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06
N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06
N204275-001	8511304*PED	2027-12-14		Pediatric extension
N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12
N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12
N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12
N204275-001	11116721*PED	2029-08-26		Pediatric extension
N204275-001	8534281	2030-03-08		Drug product	2013-09-18
N204275-001	8534281*PED	2030-09-08		Pediatric extension
N204275-001	8746242	2030-10-11		Drug product	2014-07-08
N204275-001	8746242*PED	2031-04-11		Pediatric extension
N204275-002	8511304	2027-06-14	U-1691	Drug product	2015-05-07
N204275-002	8511304	2027-06-14	U-3623	Drug product	2015-05-07
N204275-002	8511304*PED	2027-12-14		Pediatric extension
N204275-002	11116721	2029-02-26	U-1691	Drug product	2021-10-12
N204275-002	11116721	2029-02-26	U-3623	Drug product	2021-10-12
N204275-002	11116721*PED	2029-08-26		Pediatric extension
N204275-002	8534281	2030-03-08		Drug product	2015-05-07
N204275-002	8534281*PED	2030-09-08		Pediatric extension
N204275-002	8746242	2030-10-11		Drug product	2015-05-07
N204275-002	8746242*PED	2031-04-11		Pediatric extension
N204275-003	8511304	2027-06-14	U-3623	Drug product	2023-06-09
N204275-003	8511304*PED	2027-12-14		Pediatric extension
N204275-003	11116721	2029-02-26	U-3623	Drug product	2023-06-09
N204275-003	11116721*PED	2029-08-26		Pediatric extension
N204275-003	8534281	2030-03-08		Drug product	2023-06-09
N204275-003	8534281*PED	2030-09-08		Pediatric extension
N204275-003	8746242	2030-10-11		Drug product	2023-06-09
N204275-003	8746242*PED	2031-04-11		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204275-001	NPP	2026-05-13
N204275-001	PED	2026-11-13
N204275-003	NS	2026-05-13
N204275-003	PED	2026-11-13

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 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 46 · 1,815 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8511304*PED	2027-12-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	11116721*PED	2029-08-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8534281	2030-03-08		Drug product	2013-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8534281*PED	2030-09-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8746242	2030-10-11		Drug product	2014-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	8746242*PED	2031-04-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8511304	2027-06-14	U-3623	Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8511304	2027-06-14	U-1691	Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8511304*PED	2027-12-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	11116721*PED	2029-08-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8534281	2030-03-08		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8534281*PED	2030-09-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8746242	2030-10-11		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-002	8746242*PED	2031-04-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8511304	2027-06-14	U-3623	Drug product	2023-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8511304*PED	2027-12-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	11116721	2029-02-26	U-3623	Drug product	2023-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	11116721*PED	2029-08-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8534281	2030-03-08		Drug product	2023-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8534281*PED	2030-09-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8746242	2030-10-11		Drug product	2023-06-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	8746242*PED	2031-04-11		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8534281	2030-03-08		Drug product	2013-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N204275-001	NPP	2026-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-001	PED	2026-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	NS	2026-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204275-003	PED	2026-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204275-001	NPP	2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	PED	2026-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	NS	2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	PED	2026-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	NPP	2026-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	PED	2026-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	NS	2026-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-003	PED	2026-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	NPP	2026-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-001	PED	2026-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	NS	2026-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204275-003	PED	2026-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204275-001	NPP	2026-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-001	PED	2026-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	NS	2026-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204275-003	PED	2026-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	NPP	2026-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-001	PED	2026-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	NS	2026-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204275-003	PED	2026-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	NPP	2026-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-001	PED	2026-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	NS	2026-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204275-003	PED	2026-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	NPP	2026-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-001	PED	2026-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	NS	2026-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204275-003	PED	2026-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	NPP	2026-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-001	PED	2026-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	NS	2026-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204275-003	PED	2026-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	NPP	2026-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-001	PED	2026-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	NS	2026-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204275-003	PED	2026-11-13	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Breo Ellipta
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE FUROATE	50 ug/1
VILANTEROL TRIFENATATE	25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JS86977WNV	Internal UNII lookup
40AHO2C6DG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1424889	Internal RxNorm lookup
1424899	Internal RxNorm lookup
1539891	Internal RxNorm lookup
1539893	Internal RxNorm lookup
1648783	Internal RxNorm lookup
1648785	Internal RxNorm lookup
1648788	Internal RxNorm lookup
1648789	Internal RxNorm lookup
2637473	Internal RxNorm lookup
2637476	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96428df1-ea05-431a-98d3-1ec2c4b63878	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
c982201d-72cb-462f-9e02-902ec0d4a295	Product name	1	20181030
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0173-0916-10	Breo Ellipta	1 in 1 TRAY	POWDER	1		28
0173-0916-10	Breo Ellipta	1 in 1 CARTON	POWDER	1		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0916-10	EA - Each	0173-0916	b62320f4-1868-495c-b507-e5e122c9dd6f	1	2023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUTICASONE FUROATE	ACTIVE INGREDIENT	JS86977WNV	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8
VILANTEROL TRIFENATATE	ACTIVE INGREDIENT	40AHO2C6DG	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8
FLUTICASONE	ACTIVE MOIETY	CUT2W21N7U	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8
VILANTEROL	ACTIVE MOIETY	028LZY775B	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0916	BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	28	Current NDC, 2 package rows	20250521_96428df1-ea05-431a-98d3-1ec2c4b63878.zip

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Furoate and Vilanterol	FLUTICASONE FUROATE AND VILANTEROL	Prasco Laboratories	3a761487-c300-451a-8537-3196c00c11b5	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204275 application number: NDA204275
Breo Ellipta	FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE	GlaxoSmithKline LLC	96428df1-ea05-431a-98d3-1ec2c4b63878	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204275 application number: NDA204275 ndc (product): 0173-0916

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JS86977WNV	FLUTICASONE FUROATE	397864-44-7	FLUTICASONE FUROATE
40AHO2C6DG	VILANTEROL TRIFENATATE	503070-58-4	VILANTEROL TRIFENATATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1539891	Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539893	Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648785	Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648789	Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637476	Breo Ellipta 50/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637473	fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1424899	fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1424889	fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648783	fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 14 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648788	fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539891	14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]	SBD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648785	14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]	SBD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637476	30 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]	SBD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539893	30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]	SBD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648789	30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]	SBD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1424899	14 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648783	14 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637473	30 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1424889	30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648788	30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539891	Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539893	Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539891	Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539893	Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648785	Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648789	Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648785	Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648789	Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637476	Breo Ellipta (fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1539891	Breo Ellipta Institutional Pack	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648788	fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
2637473	fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28
1648788	fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	SY	96428df1-ea05-431a-98d3-1ec2c4b63878	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0173-0916-10	00173091610	1 TRAY in 1 CARTON (0173-0916-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	1 tray	2023-05-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Breo Ellipta - GlaxoSmithKline LLC	GlaxoSmithKline LLC	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	29