Home NDC 66993-134 Umeclidinium and Vilanterol Ellipta
Product NDC 66993-134
11-digit product format 669930134
Labeler code 66993
Product ID 66993-134_bffa73f4-99ab-49a2-b585-0982dd611110
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name umeclidinium bromide and vilanterol trifenatate
Dosage form POWDER
Route RESPIRATORY (INHALATION)
Labeler Prasco Laboratories
Application NDA203975
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-04-11
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 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 N203975-001 ANORO ELLIPTA EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203975-001 ANORO ELLIPTA EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-12-18 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 16 · 622 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 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8309572 2025-04-27 U-1476 2014-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 7439393 2025-05-21 U-1476 Drug substance, Drug product 2014-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8183257 2025-07-27 U-1476 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 7439393*PED 2025-11-21 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8511304 2027-06-14 U-1476 Drug product 2014-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 9333310 2027-10-02 Drug product 2016-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8511304*PED 2027-12-14 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 7488827 2027-12-18 Drug substance, Drug product 2014-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8161968 2028-02-05 Drug product 2014-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 9333310*PED 2028-04-02 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8161968*PED 2028-08-05 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203975-001 8534281 2030-03-08 Drug product 2014-01-09 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Umeclidinium and Vilanterol 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1487527 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 66993-134-97 Umeclidinium and Vilanterol Ellipta 1 in 1 TRAY POWDER 1 3 66993-134-97 Umeclidinium and Vilanterol Ellipta 1 in 1 CARTON POWDER 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-134 UMECLIDINIUM AND VILLANTEROL ELLIPTA (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE) POWDER [PRASCO LABORATORIES] 1 Current NDC, 2 package rows 20250416_6de414b1-f707-4b98-9e4b-742032ec90af.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66993-134-97 66993013497 1 TRAY in 1 CARTON (66993-134-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER 1 tray 2025-04-11 No No Current