Label: HELIUM gas

  • NDC Code(s): 59579-005-01, 59579-005-02, 59579-005-03, 59579-005-04, view more
    59579-005-05, 59579-005-06, 59579-005-07, 59579-005-08, 59579-005-09, 59579-005-10, 59579-005-11, 59579-005-12, 59579-005-13, 59579-005-14, 59579-005-15, 59579-005-16, 59579-005-17, 59579-005-18, 59579-005-19, 59579-005-20, 59579-005-21, 59579-005-22, 59579-005-23, 59579-005-24, 59579-005-25, 59579-005-26
  • Packager: Linde Gas & Equipment Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 15, 2025

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    UN1046 HELIUM, COMPRESSED USP

    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 preventive device in the piping.
    Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use.
    Close valve after each use and when empty. Do not inhale for recreational use.
    Protect from sunlight when ambient temperature exceeds 52°C (125°F). 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. WARNING: Administration of helium 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
    helium and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration,
    and with the hazards, contraindications and side effects, and the precautions to be taken.

    Rx ONLY

    IN CASE OF EMERGENCY: CALL 1-800-645-4633

    CAS: 7440-59-7

    Medipure By Linde

    Linde

    DO NOT REMOVE THIS LABEL MDS-0003 (Rev. 01)

    DISTRIBUTED BY LINDE INC., DANBURY, CT 06810-6268

    helium

  • INGREDIENTS AND APPEARANCE
    HELIUM 
    helium gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59579-005
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59579-005-0114696 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    2NDC:59579-005-0212233 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    3NDC:59579-005-039430 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    4NDC:59579-005-048240 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    5NDC:59579-005-056909 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    6NDC:59579-005-066173 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    7NDC:59579-005-073823 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    8NDC:59579-005-083087 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    9NDC:59579-005-092067 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    10NDC:59579-005-101048 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    11NDC:59579-005-11623 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    12NDC:59579-005-12510 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    13NDC:59579-005-15368 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    14NDC:59579-005-16113 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    15NDC:59579-005-17170 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    16NDC:59579-005-186768 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    17NDC:59579-005-192209 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    18NDC:59579-005-20821 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    19NDC:59579-005-13538 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    20NDC:59579-005-14142 L in 1 CYLINDER; Type 0: Not a Combination Product12/01/2007
    21NDC:59579-005-2199 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    22NDC:59579-005-2299 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    23NDC:59579-005-2357 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    24NDC:59579-005-243820 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    25NDC:59579-005-25396 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    26NDC:59579-005-261444 L in 1 CYLINDER; Type 0: Not a Combination Product01/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20591212/01/2007
    Labeler - Linde Gas & Equipment Inc. (042845636)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.161317490manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.045252439manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.159890391manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.049964372manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.027514424manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.080185766manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.196953322manufacture(59579-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Gas & Equipment Inc.948364559manufacture(59579-005)