OXYGEN- oxygen gas
Advanced Home Care

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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Oxygen, USP

Principal for Oxygen Product

representative label

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55813-123
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: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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		10/27/2015

Labeler - Advanced Home Care (603161209)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		008930102	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc		031557958	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		073459898	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc		078652894	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		078818616	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		079708390	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		118915730	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc.		603161209	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc		620931506	manufacture(55813-123)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Home Care, Inc		828372693	manufacture(55813-123)

Revised: 11/2015

Document Id: 23bde802-d853-1ecc-e054-00144ff88e88

Set id: 23be7076-e6b1-3465-e054-00144ff88e88

Version: 1

Effective Time: 20151104

Advanced Home Care