OXYGEN- oxygen gas
Rotech Healthcare Inc

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.

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2018 DRUG REGISTRATION LISTING

Oxygen Compressed

Oxygen Compressed

Oxygen Refrigerated Liquid

Oxygen Refrigerated Liquid

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57439-000
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L in 100 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		01/01/2018

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57439-001
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L in 100 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		01/01/2018

Labeler - Rotech Healthcare Inc (144556222)

Name	Address	ID/FEI	Business Operations
Establishment
HOME CARE MEDICAL SERVICES		169932436	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ACTIVE CARE		174392501	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
SENTRY HOME HEALTH		796502123	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
THE OXYGEN STORE		949995476	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ALLIED MEDICAL SUPPLY		079488272	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		159346050	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
SUMMIT RESPIRATORY		135922784	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
SUMMIT RESPIRATORY		874476422	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
OXYGEN PLUS		796499858	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTH MEDICAL		179387050	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
SUMMIT RESPIRATORY		831552372	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTH MEDICAL		144369613	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
G & G MEDICAL		796502479	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
G & G MEDICAL		085400138	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
DON PAUL RESPIRATORY SERVICES		796500895	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTH MEDICAL		831552364	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
SUMMIT RESPIRATORY		079569918	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTH MEDICAL		948744180	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		831562918	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
KELLEY'S HOME HEALTH SERVICES		079738768	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
FAMILY HOME CARE		831748491	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MEDSOURCE		079713679	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
HOOK'S OXYGEN & MEDICAL EQUIPMENT		079607405	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		098136096	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
FIRST CARE		079639101	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
GREAT LAKES HOME MEDICAL		831831172	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MIDLAND OXYGEN & MEDICAL SUPPLY		016953296	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
HEARTLAND HOME HEALTH CARE		079570162	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
HOME CARE MEDICAL		079721579	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		611480690	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		833186922	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MAJOR MEDICAL		079607401	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MAJOR MEDICAL		079607390	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
VITALCARE HEALTH SERVICES		956721187	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
CAMBRIA MEDICAL SUPPLY		620007021	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
CPO2		148713329	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
NORTHEAST MEDICAL EQUIPMENT INC		079531825	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		058159881	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
HOME MEDICAL SYSTEMS		795469142	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		079738728	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MAJOR MEDICAL SUPPLY		079721904	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
MED-AIR TRANSFILL		841973667	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
RHEMA MEDICAL		078670599	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH		079570216	manufacture(57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
ROTECH HOME MEDICAL CARE		079607622	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
COMMUNITY HOME OXYGEN		079607617	manufacture(57439-000, 57439-001)

Name	Address	ID/FEI	Business Operations
Establishment
COMMUNITY HOME OXYGEN		796499213	manufacture(57439-001)

Revised: 1/2018

Document Id: be8d7d5b-eaf5-42b7-94a5-18b4bb43858f

Set id: 5991bebb-91c0-4fe0-8bbe-7cdc75de173b

Version: 4

Effective Time: 20180110

Rotech Healthcare Inc