Nitrogen

Manufacturer: Roberts Oxygen Company, Inc.
Effective date: 2025-11-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:46:14

Label at a glance#

ProductNitrogen

Active ingredientNITROGEN

Label structure1 sections

Contacts and useful links#

PhoneLabel contact(301) 948-8100

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100

CERTIFICATE OF ANALYSIS
NITROGEN REFRIGERATED LIQUID, NF*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE: _________________

LOT#: _________________

*NF applies only when used in a medical application or by medical customers properly registered with the FDA.

Component Test Method Limit Result

NITROGEN DIFF >99.999% _______

OXYGEN ________ <3.0 PPM _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as NITROGEN, NF through process validations, dedicated piping, and product specific connections.

Notes: _____________________________________

RELEASED BY: ____________________________

SIGNATURE

RELEASED BY: ____________________________

PRINTED NAME

Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP

(800) 327-6868 *jjkeller.com * Printer in the Unitied States

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311998	nitrogen 99 % Gas for Inhalation	PSN	2
311998	nitrogen 99 % Gas for Inhalation	SCD	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46123-440-01	Nitrogen	1 L in 1 TANK	GAS	1		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Nitrogen

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46123-440	46123-440-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NITROGEN	N762921K75	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

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	Roberts Oxygen Company, Inc.	2bed6bd8-086e-ee30-e063-6394a90ad420	2025-11-17		Exact identifier ndc (package): 46123-440-01 ndc (product): 46123-440 ndc11 (package): 46123044001 spl id: 43ced637-115d-0659-e063-6394a90a6810 spl set id: 2bed6bd8-086e-ee30-e063-6394a90ad420

Reported adverse events (FAERS/openFDA)#

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