Anoro Ellipta

Product NDC: 0173-0869
11-digit product format: 001730869
Labeler code: 0173
Product ID: 0173-0869_90be6e26-9d2d-4b9d-8378-5e38c3076720
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: umeclidinium bromide and vilanterol trifenatate
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: GlaxoSmithKline LLC
Application: NDA203975
Marketing category: NDA
Marketing start: 2014-01-31
Substance: UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active strength: 62.5; 25 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0173-0869	0173-0869-61	D	Discontinued by firm		2026-10-05

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203975-001	ANORO ELLIPTA	UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION		RLD, RS	2013-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09
N203975-001	8511304*PED	2027-12-14		Pediatric extension
N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09
N203975-001	11090294	2030-11-29	U-3203		2021-09-14
N203975-001	12396986	2030-11-29		Drug product	2025-09-19
N203975-001	9750726	2030-11-29		Drug product	2017-09-21

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 2 · 43 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	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203975-001	ANORO ELLIPTA	EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	POWDER / INHALATION	RLD, RS	2013-12-18	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 634 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	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8309572	2025-04-27	U-1476		2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7439393	2025-05-21	U-1476	Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8183257	2025-07-27	U-1476			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7439393*PED	2025-11-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	12396986	2030-11-29		Drug product	2025-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8309572	2025-04-27	U-1476		2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7439393	2025-05-21	U-1476	Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8183257	2025-07-27	U-1476			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7439393*PED	2025-11-21		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8511304	2027-06-14	U-1476	Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	8511304*PED	2027-12-14		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	7488827	2027-12-18		Drug substance, Drug product	2014-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	11090294	2030-11-29	U-3203		2021-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203975-001	9750726	2030-11-29		Drug product	2017-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203975-001	7498440	2025-04-27		Drug substance, Drug product	2014-01-09	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203975-001	M-245	2022-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203975-001	M-245	2022-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203975-001	M-245	2022-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203975-001	M-245	2022-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203975-001	M-245	2022-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203975-001	M-245	2022-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203975-001	M-245	2022-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203975-001	M-245	2022-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203975-001	M-245	2022-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203975-001	M-245	2022-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203975-001	M-245	2022-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203975-001	M-245	2022-06-09	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	N203975-001	M-245	2022-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203975-001	M-245	2022-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203975-001	M-245	2022-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203975-001	M-245	2022-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203975-001	M-245	2022-06-09	`cb3db0bc1861…`

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: Anoro Ellipta
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UMECLIDINIUM BROMIDE	62.5 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
7AN603V4JV	Internal UNII lookup
40AHO2C6DG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1487519	Internal RxNorm lookup
1487524	Internal RxNorm lookup
1487527	Internal RxNorm lookup
1487528	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
2dbd0671-c565-40c5-bf0f-e324db26799c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
b8f051f0-c83d-4101-9511-7c3765599726	Product name	1	20190910
c982201d-72cb-462f-9e02-902ec0d4a295	Product name	1	20181030
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0173-0869-06	Anoro Ellipta	1 in 1 CARTON	POWDER	1	29
0173-0869-06	Anoro Ellipta	1 in 1 TRAY	POWDER	1	29
0173-0869-10	Anoro Ellipta	1 in 1 TRAY	POWDER	1	29
0173-0869-10	Anoro Ellipta	1 in 1 CARTON	POWDER	1	29
0173-0869-61	Anoro Ellipta	1 in 1 CARTON	POWDER	1	29
0173-0869-61	Anoro Ellipta	1 in 1 TRAY	POWDER	1	29

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
UMECLIDINIUM BROMIDE	ACTIVE INGREDIENT	7AN603V4JV	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7
VILANTEROL TRIFENATATE	ACTIVE INGREDIENT	40AHO2C6DG	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7
UMECLIDINIUM	ACTIVE MOIETY	GE2T1418SV	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7
VILANTEROL	ACTIVE MOIETY	028LZY775B	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0869	ANORO ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]	28	Current NDC, Legacy NDC, 6 package rows	20250101_2dbd0671-c565-40c5-bf0f-e324db26799c.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
Umeclidinium and Vilanterol Ellipta	UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE	Prasco Laboratories	6de414b1-f707-4b98-9e4b-742032ec90af	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203975 application number: NDA203975
Anoro Ellipta	UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE	GlaxoSmithKline LLC	2dbd0671-c565-40c5-bf0f-e324db26799c	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203975 application number: NDA203975 ndc (product): 0173-0869

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AN603V4JV	UMECLIDINIUM BROMIDE	869113-09-7	UMECLIDINIUM BROMIDE
40AHO2C6DG	VILANTEROL TRIFENATATE	503070-58-4	VILANTEROL TRIFENATATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1487528	ANORO Ellipta 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487524	ANORO Ellipta 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 Blisters	PSN	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487527	umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters	PSN	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487519	umeclidinium/vilanterol 62.5/25 MCG/INHAL Dry Powder Inhaler, 7 Blisters	PSN	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487528	30 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Anoro]	SBD	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487524	7 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Anoro]	SBD	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487527	30 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487519	7 ACTUAT umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler	SCD	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487528	Anoro Ellipta (umeclidinium 62.5 MCG / vilanterol 25 MCG) per ACTUAT Dry Powder Inhaler, 30 ACTUAT	SY	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487524	Anoro Ellipta (umeclidinium 62.5 MCG / vilanterol 25 MCG) per ACTUAT Dry Powder Inhaler, 7 ACTUAT	SY	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487527	umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 30 ACTUAT Dry Powder Inhaler	SY	2dbd0671-c565-40c5-bf0f-e324db26799c	29
1487519	umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT 7 ACTUAT Dry Powder Inhaler	SY	2dbd0671-c565-40c5-bf0f-e324db26799c	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0869-06	00173086906	1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER	1 tray	2014-01-31	0000-00-00	No	No	Current
0173-0869-10	00173086910	1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER	1 tray	2014-01-31	0000-00-00	No	No	Current
0173-0869-61	00173086961	1 TRAY in 1 CARTON (0173-0869-61) > 1 INHALER in 1 TRAY > 7 POWDER in 1 INHALER	1 tray	2014-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anoro Ellipta - GlaxoSmithKline LLC	GlaxoSmithKline LLC	2023-06-02	HUMAN PRESCRIPTION DRUG LABEL	29