Nitrogen

Product NDC: 23647-002
Requested package NDC: 23647-002-03
11-digit product format: 236470002
Labeler code: 23647
Product ID: 23647-002_45c700db-8d21-cf27-e063-6394a90a8c4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: SYOXSA, Inc.
Application: NDA205829
Marketing category: NDA
Marketing start: 2011-10-30
Substance: NITROGEN
Active strength: 990 mL/L
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	23647-002	23647-002-03	D	Discontinued by firm		2026-08-03

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 · 7 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…`

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrogen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGEN	990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N762921K75	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311998	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
66b47ed5-82d0-44ba-a2aa-17db9b98ee22	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
23647-002-01	Nitrogen	8608 L in 1 CYLINDER	GAS	8608	13
23647-002-02	Nitrogen	6512 L in 1 CYLINDER	GAS	6512	13
23647-002-03	Nitrogen	2265 L in 1 CYLINDER	GAS	2265	13
23647-002-04	Nitrogen	8501 L in 1 CYLINDER	GAS	8501	13
23647-002-05	Nitrogen	6453 L in 1 CYLINDER	GAS	6453	13
23647-002-06	Nitrogen	2240 L in 1 CYLINDER	GAS	2240	13
23647-002-07	Nitrogen	1052 L in 1 CYLINDER	GAS	1052	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
NITROGEN	ACTIVE INGREDIENT	N762921K75	NITROGEN GAS [SYOXSA, INC.]	1
NITROGEN	ACTIVE MOIETY	N762921K75	NITROGEN GAS [SYOXSA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23647-002	NITROGEN GAS [SYOXSA, INC.]	12	Current NDC, Legacy NDC, 7 package rows	20250124_66b47ed5-82d0-44ba-a2aa-17db9b98ee22.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
Nitrogen	NITROGEN	SYOXSA, Inc.	66b47ed5-82d0-44ba-a2aa-17db9b98ee22	2025-12-12		Exact identifier application applno (NDA): 205829 application number: NDA205829 ndc (package): 23647-002-03 ndc (product): 23647-002 ndc11 (package): 23647000203

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N762921K75	NITROGEN	7727-37-9	NITROGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311998	nitrogen 99 % Gas for Inhalation	PSN	66b47ed5-82d0-44ba-a2aa-17db9b98ee22	13
311998	nitrogen 99 % Gas for Inhalation	SCD	66b47ed5-82d0-44ba-a2aa-17db9b98ee22	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23647-002-03	23647000203	2265 L in 1 CYLINDER (23647-002-03)	2265 l	2011-10-30	0000-00-00	No	No	Current