FDA.reportPublic FDA data

Trelegy Ellipta

Product NDC
0173-0893
11-digit product format
001730893
Labeler code
0173
Product ID
0173-0893_3adf47cb-c3b5-4fdb-9441-d90679b79687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA209482
Marketing category
NDA
Marketing start
2020-09-09
Substance
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Active strength
200; 62.5; 25 ug/1; ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209482-001TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18
N209482-002TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209482-00174888272027-12-18Drug substance, Drug product2017-10-06
N209482-00185342812030-03-08Drug product2017-10-06
N209482-0018534281*PED2030-09-08Pediatric extension
N209482-00187462422030-10-11Drug product2017-10-06
N209482-001110902942030-11-29U-32022021-09-14
N209482-001123969862030-11-29Drug product2025-09-18
N209482-00197507262030-11-29Drug product2017-10-06
N209482-0018746242*PED2031-04-11Pediatric extension
N209482-00274888272027-12-18Drug substance, Drug product2020-10-06
N209482-00285342812030-03-08Drug product2020-10-06
N209482-0028534281*PED2030-09-08Pediatric extension
N209482-00287462422030-10-11Drug product2020-10-06
N209482-002123969862030-11-29Drug product2025-09-18
N209482-00297507262030-11-29Drug product2020-10-06
N209482-0028746242*PED2031-04-11Pediatric extension

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209482-002TRELEGY ELLIPTA0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2020-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209482-001TRELEGY ELLIPTA0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2017-09-18782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,346 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209482-00174888272027-12-18Drug substance, Drug product2017-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00185342812030-03-08Drug product2017-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-0018534281*PED2030-09-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00187462422030-10-11Drug product2017-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-001110902942030-11-29U-32022021-09-14caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-001123969862030-11-29Drug product2025-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00197507262030-11-29Drug product2017-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-0018746242*PED2031-04-11Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00274888272027-12-18Drug substance, Drug product2020-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00285342812030-03-08Drug product2020-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-0028534281*PED2030-09-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00287462422030-10-11Drug product2020-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-002123969862030-11-29Drug product2025-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-00297507262030-11-29Drug product2020-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209482-0028746242*PED2031-04-11Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209482-00174888272027-12-18Drug substance, Drug product2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00185342812030-03-08Drug product2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-0018534281*PED2030-09-08Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00187462422030-10-11Drug product2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-001110902942030-11-29U-32022021-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-001123969862030-11-29Drug product2025-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00197507262030-11-29Drug product2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-0018746242*PED2031-04-11Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00274888272027-12-18Drug substance, Drug product2020-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00285342812030-03-08Drug product2020-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-0028534281*PED2030-09-08Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00287462422030-10-11Drug product2020-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-002123969862030-11-29Drug product2025-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-00297507262030-11-29Drug product2020-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209482-0028746242*PED2031-04-11Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00174984402025-04-27Drug substance, Drug product2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00183095722025-04-27U-21292017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00174393932025-05-21U-2127Drug substance, Drug product2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00174393932025-05-21U-2957Drug substance, Drug product2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00181832572025-07-27U-21282017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00181832572025-07-27U-21292017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-0017439393*PED2025-11-21Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00174888272027-12-18Drug substance, Drug product2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-00185342812030-03-08Drug product2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209482-0018534281*PED2030-09-08Pediatric extension31067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209482-001I-8432023-09-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209482-002NS2023-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209482-001I-8432023-09-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209482-002NS2023-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209482-001I-8432023-09-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209482-002NS2023-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209482-001I-7752021-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209482-001I-8432023-09-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209482-002NS2023-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209482-001I-7752021-04-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N209482-001I-8432023-09-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N209482-002NS2023-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209482-001I-7752021-04-2487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209482-001I-8432023-09-0987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209482-002NS2023-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N209482-001I-7752021-04-245aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209482-001I-8432023-09-095aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N209482-002NS2023-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209482-001I-7752021-04-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209482-001I-8432023-09-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N209482-002NS2023-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209482-001I-7752021-04-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209482-001I-7752021-04-243f01610625f2…
2019-09-15 20:21 UTC2019-09N209482-001I-7752021-04-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N209482-001I-7752021-04-24ea99ee380514…
2023-12-20 04:57 UTC2023-12N209482-001I-8432023-09-09ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N209482-002NS2023-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209482-001I-8432023-09-09a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209482-002NS2023-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209482-001I-8432023-09-099b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209482-002NS2023-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209482-001I-8432023-09-09a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209482-002NS2023-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209482-001I-8432023-09-093f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209482-002NS2023-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N209482-001I-8432023-09-09053a50430f4f…
2023-05-13 08:27 UTC2023-05N209482-002NS2023-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N209482-001I-8432023-09-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N209482-002NS2023-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209482-001I-8432023-09-093a93d1ddd44b…

Additional Listing Data#

Finished product
Yes
Brand name base
Trelegy Ellipta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE200 ug/1
UMECLIDINIUM BROMIDE62.5 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AN603V4JVInternal UNII lookup
40AHO2C6DGInternal UNII lookup
JS86977WNVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1945039Internal RxNorm lookup
1945044Internal RxNorm lookup
1945047Internal RxNorm lookup
1945048Internal RxNorm lookup
2395769Internal RxNorm lookup
2395771Internal RxNorm lookup
2395774Internal RxNorm lookup
2395775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5a81d5a-4648-4c7a-951d-33c014a63c7eAvailable on FDA.report

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
b8f051f0-c83d-4101-9511-7c3765599726Product name120190910
c982201d-72cb-462f-9e02-902ec0d4a295Product name120181030
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
0173-0893-10Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0893-10Trelegy Ellipta1 in 1 TRAYPOWDER114
0173-0893-14Trelegy Ellipta1 in 1 TRAYPOWDER114
0173-0893-14Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0893-61Trelegy Ellipta1 in 1 CARTONPOWDER114
0173-0893-61Trelegy Ellipta1 in 1 TRAYPOWDER114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0893TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]12Current NDC, Legacy NDC, 6 package rows20240302_b5a81d5a-4648-4c7a-951d-33c014a63c7e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trelegy ElliptaFLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATEGlaxoSmithKline LLCb5a81d5a-4648-4c7a-951d-33c014a63c7e2023-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 209482
application number: NDA209482
ndc (product): 0173-0893

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1945039fluticasone furoate 100 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945047fluticasone furoate 100 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUAPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395769fluticasone furoate 200 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395774fluticasone furoate 200 MCG/ACTUAT / umeclidinium 62.5 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945044TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945048TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 30 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395771TRELEGY ELLIPTA 200 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395775TRELEGY ELLIPTA 200 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 30 BlistersPSNb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504414 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577114 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504830 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577530 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Trelegy]SBDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194503914 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239576914 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
194504730 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
239577430 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / umeclidinium 0.0625 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCDb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945039fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945047fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395769fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395774fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945044Trelegy Ellipta (fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
1945048Trelegy Ellipta (fluticasone furoate 100 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395771Trelegy Ellipta (fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14
2395775Trelegy Ellipta (fluticasone furoate 200 MCG/ACTUAT / umeclidinium (as umeclidinium Br) 62.5 MCG/ACTUAT / vilanterol (as vilanterol trifenatate) 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSYb5a81d5a-4648-4c7a-951d-33c014a63c7e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0893-10001730893101 TRAY in 1 CARTON (0173-0893-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2020-09-090000-00-00NoNoCurrent
0173-0893-14001730893141 TRAY in 1 CARTON (0173-0893-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER1 tray2020-09-090000-00-00NoNoCurrent
0173-0893-61001730893611 TRAY in 1 CARTON (0173-0893-61) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER1 tray2020-09-090000-00-00YesNoCurrent