Home NDC 66993-189 Umeclidinium Ellipta
Product NDC 66993-189
11-digit product format 669930189
Labeler code 66993
Product ID 66993-189_78029af6-3c01-4be0-8439-ec3c22b4abb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name umeclidinium
Dosage form AEROSOL, POWDER
Route ORAL
Labeler Prasco Laboratories
Application NDA205382
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-04-06
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 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205382-001 INCRUSE ELLIPTA EQ 62.5MCG BASE/INH POWDER / INHALATION RLD, RS 2014-04-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 9 · 344 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205382-001 8309572 2025-04-27 U-1476 2014-05-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205382-001 8183257 2025-07-27 U-1476 2014-05-21 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Umeclidinium 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1539251 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 66993-189-97 Umeclidinium Ellipta 1 in 1 CARTON AEROSOL, POWDER 1 2 66993-189-97 Umeclidinium Ellipta 1 in 1 TRAY AEROSOL, POWDER 1 2
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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66993-189-97 66993018997 1 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER 1 tray 2026-04-06 No No Current