Home NDC 0173-0873 Incruse Ellipta
Product NDC 0173-0873
11-digit product format 001730873
Labeler code 0173
Product ID 0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name umeclidinium
Dosage form AEROSOL, POWDER
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA205382
Marketing category NDA
Marketing start 2014-04-30
Substance UMECLIDINIUM BROMIDE
Active strength 62.5 ug/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205382-001 INCRUSE ELLIPTA UMECLIDINIUM BROMIDE EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205382-001 INCRUSE ELLIPTA EQ 0.0625MG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 9 · 346 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 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 9333310 2027-10-02 Drug product 2016-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 8201556 2029-02-05 Drug product 2014-05-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205382-001 8746242 2030-10-11 Drug product 2014-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 9333310 2027-10-02 Drug product 2016-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 8201556 2029-02-05 Drug product 2014-05-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205382-001 8746242 2030-10-11 Drug product 2014-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 9333310 2027-10-02 Drug product 2016-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 8201556 2029-02-05 Drug product 2014-05-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205382-001 8746242 2030-10-11 Drug product 2014-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 9333310 2027-10-02 Drug product 2016-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 7488827 2027-12-18 Drug substance, Drug product 2014-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 8201556 2029-02-05 Drug product 2014-05-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205382-001 8746242 2030-10-11 Drug product 2014-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205382-001 7498440 2025-04-27 Drug substance, Drug product 2014-05-21 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Incruse Ellipta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UMECLIDINIUM BROMIDE 62.5 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AN603V4JV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1539251 Internal RxNorm lookup 1539885 Internal RxNorm lookup 1596444 Internal RxNorm lookup 1596445 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0173-0873-06 Incruse Ellipta 1 in 1 CARTON AEROSOL, POWDER 1 27 0173-0873-06 Incruse Ellipta 1 in 1 TRAY AEROSOL, POWDER 1 27 0173-0873-10 Incruse Ellipta 1 in 1 TRAY AEROSOL, POWDER 1 27 0173-0873-10 Incruse Ellipta 1 in 1 CARTON AEROSOL, POWDER 1 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0173-0873 INCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC] 25 Current NDC, Legacy NDC, 4 package rows 20250525_dbb64747-1505-49d7-9a33-99dd402e96d3.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.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1539885 Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters PSN dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596445 Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 7 Blisters PSN dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539251 umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters PSN dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596444 umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 7 Blisters PSN dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539885 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse] SBD dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596445 7 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse] SBD dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539251 30 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler SCD dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596444 7 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler SCD dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539885 Incruse Ellipta (umeclidinium 62.5 MCG) per ACTUAT Dry Powder Inhaler, 30 ACTUAT SY dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596445 Incruse Ellipta (umeclidinium 62.5 MCG) per ACTUAT Dry Powder Inhaler, 7 ACTUAT SY dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539885 Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters SY dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596445 Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 7 Blisters SY dbb64747-1505-49d7-9a33-99dd402e96d3 27 1539251 umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 Blisters SY dbb64747-1505-49d7-9a33-99dd402e96d3 27 1596444 umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 7 Blisters SY dbb64747-1505-49d7-9a33-99dd402e96d3 27
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0173-0873-06 00173087306 1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER 1 tray 2014-04-30 0000-00-00 No No Current 0173-0873-10 00173087310 1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER 1 tray 2014-04-30 0000-00-00 No No Current 0173-0873-61 00173087361 1 TRAY in 1 CARTON (0173-0873-61) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER 1 tray 2014-04-30 0000-00-00 No No Current