Nitrogen

Product NDC: 53425-002
Requested package NDC: 53425-002-03
11-digit product format: 534250002
Labeler code: 53425
Product ID: 53425-002_4573f404-a9b1-390c-e063-6394a90a4221
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: IWS Gas and Supply of Texas, LTD
Application: NDA205713
Marketing category: NDA
Marketing start: 2011-11-01
Substance: NITROGEN
Active strength: 995 mL/L
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
bfe95982-1606-4878-95b0-5d3bc662cc2c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53425-002-01	Nitrogen	396 L in 1 CYLINDER	GAS	396	13
53425-002-02	Nitrogen	651 L in 1 CYLINDER	GAS	651	13
53425-002-03	Nitrogen	2973 L in 1 CYLINDER	GAS	2973	13
53425-002-04	Nitrogen	5947 L in 1 CYLINDER	GAS	5947	13
53425-002-05	Nitrogen	6513 L in 1 CYLINDER	GAS	6513	13
53425-002-06	Nitrogen	6626 L in 1 CYLINDER	GAS	6626	13
53425-002-07	Nitrogen	7221 L in 1 CYLINDER	GAS	7221	13
53425-002-08	Nitrogen	7900 L in 1 CYLINDER	GAS	7900	13
53425-002-09	Nitrogen	8608 L in 1 CYLINDER	GAS	8608	13
53425-002-10	Nitrogen	180 L in 1 DEWAR	GAS	180	13
53425-002-11	Nitrogen	200 L in 1 DEWAR	GAS	200	13
53425-002-12	Nitrogen	3256 L in 1 CYLINDER	GAS	3256	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitrogen	ACTIVE INGREDIENT	N762921K75	NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]	2
Nitrogen	ACTIVE MOIETY	N762921K75	NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53425-002	NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]	12	Current NDC, Legacy NDC, 12 package rows	20241030_bfe95982-1606-4878-95b0-5d3bc662cc2c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Nitrogen	NITROGEN	Arcet Equipment Company dba Arc3 Gases North	ff2ba9fb-e58a-4e57-8e96-b7e90cc6e2a8	2026-06-18	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	DJB Gas Services, Inc	b28d71c9-b258-4d88-81e5-c84cd4981a82	2026-02-26	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	IWS Gas and Supply of Texas, LTD	bfe95982-1606-4878-95b0-5d3bc662cc2c	2025-12-08	Exact identifier application applno (NDA): 205713 application number: NDA205713 ndc (package): 53425-002-03 ndc (product): 53425-002 ndc11 (package): 53425000203
Nitrogen	NITROGEN	Gas and Supply	58dddf10-09e2-4ae6-883d-c5a9ed83d3a7	2025-12-03	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	Super Gas, Inc.	80a178d8-7173-4e7a-ace9-7fe3fd0e0724	2025-11-26	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	Central Welding Supply Company	b0bee448-ad4c-4538-8caf-72706370fad1	2025-10-28	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	HARTMAN BROTHERS, INC.	123ca615-78ce-4bc8-bcae-168c4740c230	2025-10-24	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	Wesco Gas & Welding Supply, Inc.	ea2a3b5d-f53f-49cd-9e43-708f69879cce	2025-10-13	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	B & J Welding Supply, LTD. dba B & J Welding Supply	4faa22a2-442c-4b2a-badc-c4e502493d08	2025-10-09	Exact identifier application applno (NDA): 205713 application number: NDA205713
Nitrogen	NITROGEN	GIBBS WELDING SUPPLY, INC.	227ee46a-2050-4e11-bfa9-6b1cc1634302	2025-10-08	Exact identifier application applno (NDA): 205713 application number: NDA205713

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	bfe95982-1606-4878-95b0-5d3bc662cc2c	13
347021	nitrogen 99.5 % Gas for Inhalation	SCD	bfe95982-1606-4878-95b0-5d3bc662cc2c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53425-002-03	53425000203	2973 L in 1 CYLINDER (53425-002-03)	2973 l	2011-11-01	0000-00-00	No	No	Current