Nitrogen by Roberts Oxygen Company, Inc / Roberts Oxygen Company, Inc. NITROGEN gas

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by Roberts Oxygen Company, Inc, Roberts Oxygen Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NITROGEN,
COMPRESSED
NF
UN1066
NON-FLAMMABLE GAS 2
Rx only. WARNING: Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventative device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52ºC (125ºF). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 46123-003
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46123-003-01	396 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
2	NDC: 46123-003-02	651 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
3	NDC: 46123-003-03	1698 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
4	NDC: 46123-003-04	3653 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
5	NDC: 46123-003-05	7219 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
6	NDC: 46123-003-06	8776 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
7	NDC: 46123-003-07	105312 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205850	01/01/1967

Labeler - Roberts Oxygen Company, Inc (042646877)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		020325953	manufacture(46123-003)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		116950907	manufacture(46123-003)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		783854045	manufacture(46123-003)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		791818008	manufacture(46123-003)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		926687468	manufacture(46123-003)