Oxygen

Manufacturer
Roberts Oxygen Company, Inc.
Effective date
2025-11-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:46:29

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CERTIFICATE OF ANALYSIS
OXYGEN REFRIGERATED LIQUID, USP*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE:  _________________

LOT#: _________________

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

Component Test Method Limit Result

Oxygen ______ >99.5% _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as OXYGEN, USP 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 labelimage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN9
312172oxygen 99 % Gas for InhalationSCD9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46123-045-01Oxygen1 L in 1 TANKGAS19

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46123-04546123-045-01

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
NameUNIIKind
OXYGENS88TT14065ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENRoberts Oxygen Company, Inc.c2b0f2bd-2ce2-4096-8aae-07d2200a015b2025-11-17Exact identifier
ndc (package): 46123-045-01
ndc (product): 46123-045
ndc11 (package): 46123004501
spl id: 43cf238d-8612-2acf-e063-6294a90a148e
spl set id: c2b0f2bd-2ce2-4096-8aae-07d2200a015b

Reported adverse events (FAERS/openFDA)#

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