Oxygen 995 mL/L
Oxygen · GAS · Toll Company
Oxygen is a respiratory gas administered by inhalation to treat low blood oxygen levels and support breathing in patients with various medical conditions. It is available by prescription and comes as a compressed gas for inhalation at a concentration of 995 mL/L.
Key Facts
- Brand Name
- Oxygen
- Generic Name
- Oxygen
- NDC Code (Product)
82457-004- Manufacturer
- Toll Company
- Strength
- 995 mL/L
- Dosage Form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA205849
- Marketing Start
- 12/17/2021
Recall History
Oklahoma Respiratory Care Inc
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Airgas Medical Services
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Let's Talk Health, Inc.
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Oklahoma Respiratory Care Inc
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
AGA Gas Inc
cGMP Deviations; trailer may not have met GMP requirements prior to filling
AtHome Medical, Inc.
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Roberts Home Medical LLC
CGMP Deviations
Medical Park Homecare, Inc
CGMP Deviations: Cylinders filled using out of date gauges.
Linde Gas LLC
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Grace Healthcare Medical, Inc
cGMP deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Full prescribing information not available for this product.
Frequently Asked Questions
What is Oxygen used for?
Oxygen is a respiratory gas administered by inhalation to treat low blood oxygen levels and support breathing in patients with various medical conditions. It is available by prescription and comes as a compressed gas for inhalation at a concentration of 995 mL/L.
Is Oxygen a controlled substance?
Oxygen is not classified as a controlled substance by the DEA.
What is the generic name for Oxygen?
The generic name for Oxygen is Oxygen. There are 1 other brand versions of Oxygen.
What is the NDC code for Oxygen 995 mL/L?
The NDC (National Drug Code) for Oxygen 995 mL/L is 82457-004, listed by Toll Company.