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NDC 75892-0001-01 OXYGEN 99 L/100L Details

OXYGEN 99 L/100L

OXYGEN is a RESPIRATORY (INHALATION) GAS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc.. The primary component is OXYGEN.

Product Information

NDC	75892-0001
Product ID	75892-001_6abddf99-ab1d-4287-bd30-6dacb318581d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OXYGEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	OXYGEN
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GAS
Route	RESPIRATORY (INHALATION)
Active Ingredient Strength	99
Active Ingredient Units	L/100L
Substance Name	OXYGEN
Labeler Name	Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA206023
Listing Certified Through	2023-12-31

Package

Package Images

NDC 75892-0001-01 (75892000101)

Pricing Information	N/A
NDC Package Code	75892-001-01
Billing NDC	75892000101
Package	21 L in 1 DEWAR (75892-001-01)
Marketing Start Date	2010-12-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7f09350-2b95-4cab-8ac1-effbf4339c45 Details

OXYGEN REFRIGERATED LIQUID USP LABEL

REFRIGERATED LIQUID

OXYGEN, REFRIGERATED LIQUID USP UN1073

OXYGEN 2

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction of resuscitative equipment. Keep out of reach of children.

Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

Produced by Air Liquefaction.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDER, CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBELS IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only the equipment of compatible materials equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID FIRST AID: IF ON SKIN: Thaw affected parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

OHIO VALLEY MEDICAL GAS & SUPPLY

1415 NORTH ROYAL AVE.

EVANSVILLE, IN 47715 • 812-423-3617

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75892-001
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
Packaging
1	NDC:75892-001-01	21 L in 1 DEWAR; Type 0: Not a Combination Product	12/22/2010
2	NDC:75892-001-02	31 L in 1 DEWAR; Type 0: Not a Combination Product	12/22/2010
3	NDC:75892-001-03	35 L in 1 DEWAR; Type 0: Not a Combination Product	12/22/2010
4	NDC:75892-001-04	40 L in 1 DEWAR; Type 0: Not a Combination Product	12/22/2010
5	NDC:75892-001-05	45 L in 1 DEWAR; Type 0: Not a Combination Product	12/22/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA206023	12/22/2010

Labeler - Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc. (626351451)

Registrant - Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc. (626351451)

Name	Address	ID/FEI	Business Operations
Establishment
Ohio Valley Medical Gas & Supply, Inc.		626351451	manufacture(75892-001)

Revised: 11/2022

Document Id: 6abddf99-ab1d-4287-bd30-6dacb318581d

Set id: b7f09350-2b95-4cab-8ac1-effbf4339c45

Version: 7

Effective Time: 20221104