Nitrogen

Product NDC: 63862-003
11-digit product format: 638620003
Labeler code: 63862
Product ID: 63862-003_42513308-bcbf-5d79-e063-6394a90ad64b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: J & M CYLINDER GASES, INC.
Application: NDA205866
Marketing category: NDA
Marketing start: 1997-11-07
Substance: NITROGEN
Active strength: 990 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	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
9af277a4-04f6-0805-e053-2a95a90a78c8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63862-003-01	Nitrogen	651.29 L in 1 CYLINDER	GAS	651.29	6
63862-003-02	Nitrogen	6512.87 L in 1 CYLINDER	GAS	6512.87	6
63862-003-03	Nitrogen	160 L in 1 DEWAR	GAS	160	6
63862-003-04	Nitrogen	180 L in 1 DEWAR	GAS	180	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63862-003	NITROGEN GAS [J & M CYLINDER GASES, INC.]	5	Current NDC, 4 package rows	20241102_9af277a4-04f6-0805-e053-2a95a90a78c8.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGEN	NITROGEN	Air Source Industries Inc	830d7d78-afa8-49bc-8c00-4d66eb72b83c	2024-10-06		Exact identifier application applno (NDA): 205866 application number: NDA205866
Nitrogen	NITROGEN	Air Products and Chemicals, Inc.	e4c5b56e-4c06-4980-8669-6df35e240bf9	2018-12-14		Exact identifier application applno (NDA): 205866 application number: NDA205866

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	9af277a4-04f6-0805-e053-2a95a90a78c8	6
311998	nitrogen 99 % Gas for Inhalation	SCD	9af277a4-04f6-0805-e053-2a95a90a78c8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63862-003-01	63862000301	651.29 L in 1 CYLINDER (63862-003-01)	651.29 l	1997-11-07	No	No	Current
63862-003-02	63862000302	6512.87 L in 1 CYLINDER (63862-003-02)	6512.87 l	1997-11-07	No	No	Current
63862-003-03	63862000303	160 L in 1 DEWAR (63862-003-03)	160 l	1997-11-07	No	No	Current
63862-003-04	63862000304	180 L in 1 DEWAR (63862-003-04)	180 l	1997-11-07	No	No	Current