Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 57439-000-01, 57439-000-02, 57439-000-03, 57439-000-04, view more57439-000-05, 57439-000-06, 57439-000-07, 57439-001-01, 57439-001-02, 57439-001-03 - Packager: Rotech Healthcare Inc
- 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 January 10, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Oxygen Compressed
- Oxygen Refrigerated Liquid
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57439-000 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:57439-000-01 170 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 2 NDC:57439-000-02 255 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 3 NDC:57439-000-03 425 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 4 NDC:57439-000-04 680 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 5 NDC:57439-000-05 1738 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 6 NDC:57439-000-06 2549 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 7 NDC:57439-000-07 3455 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2018 OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57439-001 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:57439-001-01 16750 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/2018 2 NDC:57439-001-02 24950 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/2018 3 NDC:57439-001-03 33500 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2018 Labeler - Rotech Healthcare Inc (144556222) Establishment Name Address ID/FEI Business Operations HOME CARE MEDICAL SERVICES 169932436 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ACTIVE CARE 174392501 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations SENTRY HOME HEALTH 796502123 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations THE OXYGEN STORE 949995476 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ALLIED MEDICAL SUPPLY 079488272 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 159346050 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations SUMMIT RESPIRATORY 135922784 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations SUMMIT RESPIRATORY 874476422 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations OXYGEN PLUS 796499858 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTH MEDICAL 179387050 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations SUMMIT RESPIRATORY 831552372 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTH MEDICAL 144369613 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations G & G MEDICAL 796502479 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations G & G MEDICAL 085400138 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations DON PAUL RESPIRATORY SERVICES 796500895 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTH MEDICAL 831552364 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations SUMMIT RESPIRATORY 079569918 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTH MEDICAL 948744180 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 831562918 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations KELLEY'S HOME HEALTH SERVICES 079738768 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations FAMILY HOME CARE 831748491 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MEDSOURCE 079713679 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations HOOK'S OXYGEN & MEDICAL EQUIPMENT 079607405 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 098136096 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations FIRST CARE 079639101 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations GREAT LAKES HOME MEDICAL 831831172 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MIDLAND OXYGEN & MEDICAL SUPPLY 016953296 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations HEARTLAND HOME HEALTH CARE 079570162 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations HOME CARE MEDICAL 079721579 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 611480690 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 833186922 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MAJOR MEDICAL 079607401 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MAJOR MEDICAL 079607390 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations VITALCARE HEALTH SERVICES 956721187 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations CAMBRIA MEDICAL SUPPLY 620007021 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations CPO2 148713329 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations NORTHEAST MEDICAL EQUIPMENT INC 079531825 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 058159881 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations HOME MEDICAL SYSTEMS 795469142 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 079738728 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MAJOR MEDICAL SUPPLY 079721904 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations MED-AIR TRANSFILL 841973667 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations RHEMA MEDICAL 078670599 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations ROTECH 079570216 manufacture(57439-001) Establishment Name Address ID/FEI Business Operations ROTECH HOME MEDICAL CARE 079607622 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations COMMUNITY HOME OXYGEN 079607617 manufacture(57439-000, 57439-001) Establishment Name Address ID/FEI Business Operations COMMUNITY HOME OXYGEN 796499213 manufacture(57439-001)
