Home NDC 72124-002-02 Tudorza Pressair
Product NDC 72124-002
Requested package NDC 72124-002-02
11-digit product format 721240002
Labeler code 72124
Product ID 72124-002_e5e42a8e-0d34-47a3-b337-552193a224a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aclidinium bromide
Dosage form POWDER, METERED
Route RESPIRATORY (INHALATION)
Labeler Circassia Pharmaceuticals Inc.
Application NDA202450
Marketing category NDA
Marketing start 2019-07-01
Marketing end 2023-08-31
Substance ACLIDINIUM BROMIDE
Active strength 400 ug/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N202450-001 TUDORZA PRESSAIR ACLIDINIUM BROMIDE 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10
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 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202450-001 TUDORZA PRESSAIR 0.4MG/INH POWDER, METERED / INHALATION RLD, RS 2012-07-23 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 6 · 202 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 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202450-001 10085974 2029-03-13 U-2513 Drug product 2018-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202450-001 11000517 2029-03-13 U-2513 Drug product 2021-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202450-001 RE46417 2025-02-10 U-2513 Drug substance, Drug product 2017-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202450-001 8051851 2027-04-22 Drug product 2012-08-17 79d66fd596c7…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72124-002-02 72124000202 1 POUCH in 1 CARTON (72124-002-02) > 1 INHALER in 1 POUCH > 30 POWDER, METERED in 1 INHALER 1 pouch 2019-07-01 2022-09-30 No No Current