Adasuve

Product NDC: 51097-001
Requested package NDC: 51097-001-02
11-digit product format: 510970001
Labeler code: 51097
Product ID: 51097-001_5ccbaa84-c412-1acc-e063-6394a90a8110
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loxapine
Dosage form: AEROSOL, POWDER
Route: RESPIRATORY (INHALATION)
Labeler: Alexza Pharmaceuticals, Inc.
Application: NDA022549
Marketing category: NDA
Marketing start: 2026-07-06
Substance: LOXAPINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51097-001	51097-001-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022549-001	ADASUVE	10MG	POWDER / INHALATION	RLD, RS	2012-12-21	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 318 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022549-001	8387612	2026-10-23	Drug product	2013-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022549-001	8387612	2026-10-23	Drug product	2013-03-29	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Adasuve
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOXAPINE	10 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51097-001-01	EA - Each	51097-001	4d4e5c69-fc71-4ce7-ab72-b24e19bc93ce	1	2022-06-06
51097-001-02	EA - Each	51097-001	041beafe-cb07-411c-94a4-cee74cb89b4a	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51097-001	ADASUVE (LOXAPINE) AEROSOL, POWDER [ALEXZA PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC	20241004_50e11732-7387-452d-b3e6-db3a431d5c4a.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 · 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 ndc (package): 51097-001-02 ndc (product): 51097-001 ndc11 (package): 51097000102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LER583670J	LOXAPINE	1977-10-2	LOXAPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51097-001-02	51097000102	5 INHALER in 1 CARTON (51097-001-02) / 1 AEROSOL, POWDER in 1 INHALER (51097-001-01)	5 inhaler	2026-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adasuve - Alexza Pharmaceuticals, Inc.	Alexza Pharmaceuticals, Inc.	2026-10-01	HUMAN PRESCRIPTION DRUG LABEL	9