NDC 51097-001-01 - Adasuve

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51097-001
Requested NDC: 51097-001-01
Package NDCs from labels: 51097-001-01, 51097-001-02
Manufacturer: Alexza Pharmaceuticals, Inc.
Effective date: 2026-10-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

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

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

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

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 number: NDA022549 ndc (package): 51097-001-02 ndc (package): 51097-001-01 ndc (product): 51097-001 ndc11 (package): 51097000101 spl id: 55f64763-e6eb-4ca3-e063-6394a90a2541 spl set id: 50e11732-7387-452d-b3e6-db3a431d5c4a unii: LER583670J

Reported adverse events (FAERS/openFDA)#

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