![OXYGEN GAS [ROTECH HEALTHCARE INC]](https://medic.hrt.org//dailymed/images/5991bebb-91c0-4fe0-8bbe-7cdc75de173b/Oxygen, Compressed USP Label.jpg)
![OXYGEN GAS [ROTECH HEALTHCARE INC]](https://medic.hrt.org//dailymed/images/5991bebb-91c0-4fe0-8bbe-7cdc75de173b/Oxygen, Refrigerated Liquid USP Label.jpg)
| NDC | 57439-000-01, 57439-000-02, 57439-000-03, 57439-000-04, 57439-000-05, 57439-000-06, 57439-000-07, 57439-001-01, 57439-001-02, 57439-001-03 |
| Set ID | 5991bebb-91c0-4fe0-8bbe-7cdc75de173b |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Rotech Healthcare Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- Oxygen Compressed
- Oxygen Refrigerated Liquid
-
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)
