Label: NITROGEN gas
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NDC Code(s):
46123-003-01,
46123-003-02,
46123-003-03,
46123-003-04, view more46123-003-05, 46123-003-06, 46123-003-07
- Packager: Roberts Oxygen Company, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 18, 2024
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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
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INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct 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. 080569994 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. 117356466 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)