Breo Ellipta

Product NDC
0173-0882
11-digit product format
001730882
Labeler code
0173
Product ID
0173-0882_03107b41-0bf9-463a-a6e4-956444373e81
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
2015-04-30
Substance
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Active strength
200; 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
2026-12-31
Current FDA listing
Yes

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204275-001BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATE0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10
N204275-002BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATE0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30
N204275-003BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATE0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2023-05-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204275-00185113042027-06-14U-1424Drug product2013-09-06
N204275-00185113042027-06-14U-1691Drug product2013-09-06
N204275-00185113042027-06-14U-3623Drug product2013-09-06
N204275-0018511304*PED2027-12-14Pediatric extension
N204275-001111167212029-02-26U-1401Drug product2021-10-12
N204275-001111167212029-02-26U-1691Drug product2021-10-12
N204275-001111167212029-02-26U-3623Drug product2021-10-12
N204275-00111116721*PED2029-08-26Pediatric extension
N204275-00185342812030-03-08Drug product2013-09-18
N204275-0018534281*PED2030-09-08Pediatric extension
N204275-00187462422030-10-11Drug product2014-07-08
N204275-0018746242*PED2031-04-11Pediatric extension
N204275-00285113042027-06-14U-1691Drug product2015-05-07
N204275-00285113042027-06-14U-3623Drug product2015-05-07
N204275-0028511304*PED2027-12-14Pediatric extension
N204275-002111167212029-02-26U-1691Drug product2021-10-12
N204275-002111167212029-02-26U-3623Drug product2021-10-12
N204275-00211116721*PED2029-08-26Pediatric extension
N204275-00285342812030-03-08Drug product2015-05-07
N204275-0028534281*PED2030-09-08Pediatric extension
N204275-00287462422030-10-11Drug product2015-05-07
N204275-0028746242*PED2031-04-11Pediatric extension
N204275-00385113042027-06-14U-3623Drug product2023-06-09
N204275-0038511304*PED2027-12-14Pediatric extension
N204275-003111167212029-02-26U-3623Drug product2023-06-09
N204275-00311116721*PED2029-08-26Pediatric extension
N204275-00385342812030-03-08Drug product2023-06-09
N204275-0038534281*PED2030-09-08Pediatric extension
N204275-00387462422030-10-11Drug product2023-06-09
N204275-0038746242*PED2031-04-11Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N204275-001NPP2026-05-13
N204275-001PED2026-11-13
N204275-003NS2026-05-13
N204275-003PED2026-11-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2023-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2023-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204275-002BREO ELLIPTA0.2MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2015-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204275-003BREO ELLIPTA0.05MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD2023-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204275-001BREO ELLIPTA0.1MG/INH;EQ 0.025MG BASE/INHPOWDER / INHALATIONRLD, RS2013-05-101e350fbaab3a…

Observed Orange Book patent history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204275-00185113042027-06-14U-1691Drug product2013-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00185113042027-06-14U-1424Drug product2013-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00185113042027-06-14U-3623Drug product2013-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0018511304*PED2027-12-14Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-001111167212029-02-26U-1401Drug product2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-001111167212029-02-26U-3623Drug product2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-001111167212029-02-26U-1691Drug product2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00111116721*PED2029-08-26Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00185342812030-03-08Drug product2013-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0018534281*PED2030-09-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00187462422030-10-11Drug product2014-07-08caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0018746242*PED2031-04-11Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00285113042027-06-14U-3623Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00285113042027-06-14U-1691Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0028511304*PED2027-12-14Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-002111167212029-02-26U-3623Drug product2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-002111167212029-02-26U-1691Drug product2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00211116721*PED2029-08-26Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00285342812030-03-08Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0028534281*PED2030-09-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00287462422030-10-11Drug product2015-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0028746242*PED2031-04-11Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00385113042027-06-14U-3623Drug product2023-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0038511304*PED2027-12-14Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-003111167212029-02-26U-3623Drug product2023-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00311116721*PED2029-08-26Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00385342812030-03-08Drug product2023-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0038534281*PED2030-09-08Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N204275-00387462422030-10-11Drug product2023-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-0038746242*PED2031-04-11Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204275-00185113042027-06-14U-1691Drug product2013-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-00185113042027-06-14U-1424Drug product2013-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-00185113042027-06-14U-3623Drug product2013-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-0018511304*PED2027-12-14Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-001111167212029-02-26U-1401Drug product2021-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-001111167212029-02-26U-3623Drug product2021-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-001111167212029-02-26U-1691Drug product2021-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-00111116721*PED2029-08-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-00185342812030-03-08Drug product2013-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-0018534281*PED2030-09-08Pediatric extension011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N204275-001NPP2026-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-001PED2026-11-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-003NS2026-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204275-003PED2026-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204275-001NPP2026-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-001PED2026-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-003NS2026-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204275-003PED2026-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-001NPP2026-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-001PED2026-11-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-003NS2026-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204275-003PED2026-11-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N204275-001NPP2026-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204275-001PED2026-11-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204275-003NS2026-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204275-003PED2026-11-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-001NPP2026-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-001PED2026-11-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-003NS2026-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204275-003PED2026-11-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-001NPP2026-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-001PED2026-11-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-003NS2026-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204275-003PED2026-11-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-001NPP2026-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-001PED2026-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-003NS2026-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204275-003PED2026-11-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-001NPP2026-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-001PED2026-11-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-003NS2026-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204275-003PED2026-11-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-001NPP2026-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-001PED2026-11-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-003NS2026-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204275-003PED2026-11-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-001NPP2026-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-001PED2026-11-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-003NS2026-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204275-003PED2026-11-13d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE200 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
96428df1-ea05-431a-98d3-1ec2c4b63878Available 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
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
0173-0882-10Breo Ellipta1 in 1 TRAYPOWDER128
0173-0882-10Breo Ellipta1 in 1 CARTONPOWDER128
0173-0882-14Breo Ellipta1 in 1 CARTONPOWDER128
0173-0882-14Breo Ellipta1 in 1 TRAYPOWDER128
0173-0882-61Breo Ellipta1 in 1 CARTONPOWDER128
0173-0882-61Breo Ellipta1 in 1 TRAYPOWDER128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0882-10EA - Each0173-0882975424cb-dd3c-4950-b97e-e36450ecdafd12015-07-20
0173-0882-14EA - Each0173-088236cd8140-132e-4289-86b2-e06116d3c8c612015-07-20

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0882BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) POWDER [GLAXOSMITHKLINE LLC]28Current NDC, Legacy NDC, 6 package rows20250521_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone Furoate and VilanterolFLUTICASONE FUROATE AND VILANTEROLPrasco Laboratories3a761487-c300-451a-8537-3196c00c11b52024-11-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 204275
application number: NDA204275
Breo ElliptaFLUTICASONE FUROATE AND VILANTEROL TRIFENATATEGlaxoSmithKline LLC96428df1-ea05-431a-98d3-1ec2c4b638782024-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 204275
application number: NDA204275
ndc (product): 0173-0882

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539891Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta 100/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
2637476Breo Ellipta 50/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
2637473fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1424899fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1424889fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648783fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 14 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN96428df1-ea05-431a-98d3-1ec2c4b6387828
153989114 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878514 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
263747630 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
153989330 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878930 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler [Breo]SBD96428df1-ea05-431a-98d3-1ec2c4b6387828
142489914 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878314 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
263747330 ACTUAT fluticasone furoate 0.05 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
142488930 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
164878830 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539893Breo Ellipta (fluticasone furoate 100 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648785Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 14 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648789Breo Ellipta (fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
2637476Breo Ellipta (fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT)) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1539891Breo Ellipta Institutional PackSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
2637473fluticasone furoate 50 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY96428df1-ea05-431a-98d3-1ec2c4b6387828
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersSY96428df1-ea05-431a-98d3-1ec2c4b6387828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0882-10001730882101 TRAY in 1 CARTON (0173-0882-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2015-04-300000-00-00NoNoCurrent
0173-0882-14001730882141 TRAY in 1 CARTON (0173-0882-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER1 tray2015-04-300000-00-00NoNoCurrent
0173-0882-61001730882611 TRAY in 1 CARTON (0173-0882-61) > 1 INHALER in 1 TRAY > 14 POWDER in 1 INHALER1 tray2015-04-300000-00-00NoNoCurrent