Nitrogen

Product NDC: 53440-002
Requested package NDC: 53440-002-01
11-digit product format: 534400002
Labeler code: 53440
Product ID: 53440-002_5dd29ffc-85cb-6c5d-e063-6294a90a4cb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Westair Gases & Equipment, Inc.
Application: NDA205766
Marketing category: NDA
Marketing start: 2000-01-01
Substance: NITROGEN
Active strength: 995 mL/L
NDC exclude flag: No
Listing certified through: 2027-12-31
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	53440-002	53440-002-01	D	Discontinued by firm		2026-10-15

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 · 2 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	53440-002	53440-002-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53440-002	53440-002-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog.

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: Nitrogen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGEN	995 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
347021	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
0268620b-4e8b-4b62-a768-688b477e0171	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53440-002-01	Nitrogen	240 L in 1 DEWAR	GAS	240	17
53440-002-02	Nitrogen	230 L in 1 DEWAR	GAS	230	17
53440-002-03	Nitrogen	180 L in 1 DEWAR	GAS	180	17
53440-002-04	Nitrogen	160 L in 1 DEWAR	GAS	160	17
53440-002-05	Nitrogen	33984 L in 1 CYLINDER	GAS	33984	17
53440-002-06	Nitrogen	8496 L in 1 CYLINDER	GAS	8496	17
53440-002-07	Nitrogen	5664 L in 1 CYLINDER	GAS	5664	17
53440-002-08	Nitrogen	1416 L in 1 CYLINDER	GAS	1416	17
53440-002-09	Nitrogen	623 L in 1 CYLINDER	GAS	623	17
53440-002-10	Nitrogen	10 L in 1 CYLINDER	GAS	10	17
53440-002-11	Nitrogen	25 L in 1 CYLINDER	GAS	25	17
53440-002-12	Nitrogen	35 L in 1 CYLINDER	GAS	35	17
53440-002-13	Nitrogen	176 L in 1 CYLINDER	GAS	176	17
53440-002-14	Nitrogen	196 L in 1 CYLINDER	GAS	196	17
53440-002-15	Nitrogen	230 L in 1 CYLINDER	GAS	230	17
53440-002-16	Nitrogen	388 L in 1 CYLINDER	GAS	388	17
53440-002-17	Nitrogen	643 L in 1 CYLINDER	GAS	643	17
53440-002-18	Nitrogen	957 L in 1 CYLINDER	GAS	957	17
53440-002-19	Nitrogen	3030 L in 1 CYLINDER	GAS	3030	17
53440-002-20	Nitrogen	5863 L in 1 CYLINDER	GAS	5863	17
53440-002-21	Nitrogen	7801 L in 1 CYLINDER	GAS	7801	17
53440-002-22	Nitrogen	35778 L in 1 CYLINDER	GAS	35778	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitrogen	ACTIVE INGREDIENT	N762921K75	NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]	4
Nitrogen	ACTIVE MOIETY	N762921K75	NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53440-002	NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]	16	Current NDC, Legacy NDC, 22 package rows	20250409_0268620b-4e8b-4b62-a768-688b477e0171.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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGEN	NITROGEN	ADF Welding & Medical, Inc.	174cb8ea-66fb-4d0b-920f-01fba9537ee9	2024-10-02		Exact identifier application applno (NDA): 205766 application number: NDA205766

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
347021	nitrogen 99.5 % Gas for Inhalation	PSN	0268620b-4e8b-4b62-a768-688b477e0171	17
347021	nitrogen 99.5 % Gas for Inhalation	SCD	0268620b-4e8b-4b62-a768-688b477e0171	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53440-002-01	53440000201	240 L in 1 DEWAR (53440-002-01)	240 l	2000-01-01	0000-00-00	No	No	Current