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NDC 50597-0001-01 Oxygen 990 mL/L Details

Oxygen 990 mL/L

Oxygen is a RESPIRATORY (INHALATION) GAS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by W H GOODALE CO. The primary component is OXYGEN.

Product Information

NDC	50597-0001
Product ID	50597-001_eb3c178d-47af-5f08-e053-2995a90ab8ce
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	990
Active Ingredient Units	mL/L
Substance Name	OXYGEN
Labeler Name	W H GOODALE CO
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA205849
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50597-0001-01 (50597000101)

Pricing Information	N/A
NDC Package Code	50597-001-01
Billing NDC	50597000101
Package	415 L in 1 CYLINDER (50597-001-01)
Marketing Start Date	1987-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7031ce80-b648-eeda-e053-2991aa0aee24 Details

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

C.A.S. NO. 7782-44-7

WH Goodale Co.

Goodale Pharmarcy and Surgical Supply

16 N Sussex Street

Dover, NJ 07801

(973) 366-0976

DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODUCT LABEL.

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 of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

Produced by Air Liquefaction.

Size Contents Size Contents

M6 170 Liters E 682 Liters

C 248 Liters H 6910 Liters

D 415 Liters Other Liters

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:50597-001
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	990 mL in 1 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50597-001-01	415 L in 1 CYLINDER; Type 0: Not a Combination Product	04/14/1987
2	NDC:50597-001-02	682 L in 1 CYLINDER; Type 0: Not a Combination Product	04/14/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205849	04/14/1987

Labeler - W H GOODALE CO (011203064)

Name	Address	ID/FEI	Business Operations
Establishment
W H GOODALE CO dba GOODALE SURGICAL SUPPLY CENTER		011203064	manufacture(50597-001)

Revised: 10/2022

Document Id: eb3c178d-47af-5f08-e053-2995a90ab8ce

Set id: 7031ce80-b648-eeda-e053-2991aa0aee24

Version: 6

Effective Time: 20221017