Nitrogen

Manufacturer: Roberts Oxygen Company, Inc.
Effective date: 2020-11-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:06:14

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46123-044-01	2025-01-17	C162847	48780-1	d6a99b39-7ec7-a426-e053-dadaa90af4c2	NITROGEN REFRIGERATED LIQUID, NF -044
46123-044-01	2022-01-28	C162847	48780-1	d6a99b39-7ec7-a426-e053-dadaa90af4c2	NITROGEN REFRIGERATED LIQUID, NF -044

Products#

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

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Nitrogen

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46123-044	46123-044-01

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
2becea0d-7cc0-6b23-e063-6294a90a5a67			10211ad0-4cbd-417f-aae7-e16e4616576b	2025-01-17		Exact identifier spl set id: 10211ad0-4cbd-417f-aae7-e16e4616576b

Reported adverse events (FAERS/openFDA)#

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