Home NDC 10885-003-05 Adasuve
Product NDC 10885-003
Requested package NDC 10885-003-05
11-digit product format 108850003
Labeler code 10885
Product ID 10885-003_92cfe9f2-fd73-34d0-e053-2a95a90a4611
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loxapine
Dosage form AEROSOL, POWDER
Route RESPIRATORY (INHALATION)
Labeler Galen US Incorporated
Application NDA022549
Marketing category NDA
Marketing start 2017-09-26
Marketing end 2021-09-30
Substance LOXAPINE
Active strength 10 mg/1
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 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 N022549-001 ADASUVE LOXAPINE 10MG POWDER / INHALATION RLD, RS 2012-12-21
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 N022549-001 8387612 2026-10-23 Drug product 2013-03-29
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 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022549-001 ADASUVE 10MG POWDER / INHALATION RLD, RS 2012-12-21 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 8 · 316 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 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 9370629 2024-05-20 Drug product 2016-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 8991387 2024-05-21 Drug product 2015-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 7458374 2024-08-18 Drug product 2013-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 7537009 2024-10-28 Drug product 2013-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022549-001 8387612 2026-10-23 Drug product 2013-03-29 301d65b070ca…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Adasuve LOXAPINE Alexza Pharmaceuticals, Inc. 50e11732-7387-452d-b3e6-db3a431d5c4a 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022549 application number: NDA022549
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10885-003-05 10885000305 5 POUCH in 1 CARTON (10885-003-05) > 1 AEROSOL, POWDER in 1 POUCH (10885-003-01) 5 pouch 2017-09-26 2021-09-30 No No Current