Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 55813-123-01, 55813-123-02, 55813-123-03, 55813-123-04, view more55813-123-05, 55813-123-06, 55813-123-07, 55813-123-08 - Packager: Advanced Home Care
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 4, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Principal for Oxygen Product
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55813-123 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55813-123-02 425 L in 1 CYLINDER; Type 0: Not a Combination Product 10/27/2015 2 NDC:55813-123-03 682 L in 1 CYLINDER; Type 0: Not a Combination Product 10/27/2015 3 NDC:55813-123-04 1738 L in 1 CYLINDER; Type 0: Not a Combination Product 10/27/2015 4 NDC:55813-123-05 3455 L in 1 CYLINDER; Type 0: Not a Combination Product 10/27/2015 5 NDC:55813-123-06 46 L in 1 DEWAR; Type 0: Not a Combination Product 10/27/2015 6 NDC:55813-123-01 165 L in 1 CYLINDER; Type 0: Not a Combination Product 10/27/2015 7 NDC:55813-123-07 36 L in 1 DEWAR; Type 0: Not a Combination Product 10/27/2015 8 NDC:55813-123-08 21 L in 1 DEWAR; Type 0: Not a Combination Product 10/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 10/27/2015 Labeler - Advanced Home Care (603161209) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 008930102 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc 031557958 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 073459898 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc 078652894 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 078818616 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 079708390 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 118915730 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc. 603161209 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc 620931506 manufacture(55813-123) Establishment Name Address ID/FEI Business Operations Advanced Home Care, Inc 828372693 manufacture(55813-123)
