Breo Ellipta

Product NDC: 70518-2028
11-digit product format: 705182028
Labeler code: 70518
Product ID: 70518-2028_e3883c75-1d1c-1744-e053-2a95a90a504e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone furoate and vilanterol trifenatate
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: REMEDYREPACK INC.
Application: NDA204275
Marketing category: NDA
Marketing start: 2019-04-17
Marketing end: 0000-00-00
Substance: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Active strength: 100 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2028		D	Discontinued by firm		2026-08-17
excluded package	package	70518-2028	70518-2028-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2028-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2028-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2028-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2028-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2028-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2028-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2028-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2028-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2028-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2028-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2028-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2028-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-002	BREO ELLIPTA	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2015-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204275-003	BREO ELLIPTA	0.05MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204275-001	BREO ELLIPTA	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-05-10	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,785 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-08-18 06:07:40	2026-07	N204275-001	8746242	2030-10-11		Drug product	2014-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-001	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304	2027-06-14	U-3623	Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304	2027-06-14	U-1691	Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8534281	2030-03-08		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8746242	2030-10-11		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-002	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8511304	2027-06-14	U-3623	Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	11116721	2029-02-26	U-3623	Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	11116721*PED	2029-08-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8534281	2030-03-08		Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8534281*PED	2030-09-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8746242	2030-10-11		Drug product	2023-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204275-003	8746242*PED	2031-04-11		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-1691	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-1424	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304	2027-06-14	U-3623	Drug product	2013-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8511304*PED	2027-12-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-1401	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-3623	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721	2029-02-26	U-1691	Drug product	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	11116721*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8534281	2030-03-08		Drug product	2013-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204275-001	8534281*PED	2030-09-08		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	NPP	2026-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-001	PED	2026-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	NS	2026-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204275-003	PED	2026-11-13	`d8e5a09893c0…`

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2028-0	70518202800	1 TRAY in 1 CARTON (70518-2028-0) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER	1 tray	2019-04-17	0000-00-00	No	No	Current