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Nitrogen

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Active ingredient
Nitrogen 992 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Marketed in the U.S.
Since 1960
Label revision date
November 14, 2025
Active ingredient
Nitrogen 992 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1960
Label revision date
November 14, 2025
Manufacturer
General Distributing Company
Registration number
NDA205891
NDC root
10451-003

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If you are a consumer or patient please visit this version.

Drug Overview

Nitrogen, compressed, is a gas that is commonly used in various industrial applications. It is primarily utilized for its ability to create an inert atmosphere, which helps prevent combustion and oxidation in processes such as food packaging, chemical manufacturing, and metal fabrication.

As a compressed gas, nitrogen is stored under high pressure and is essential in many settings where a non-reactive environment is needed. It is important to handle nitrogen with care, ensuring that safety precautions are followed to prevent any risks associated with its use.

Uses

It appears that there are no specific indications or usage information provided for this drug. This means that the insert does not detail any particular conditions or situations for which the drug is intended. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development).

If you have any questions or need further information about this drug, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

When using this medication, you will administer it through your respiratory system by inhalation. This means you will breathe in the medication to help it work effectively. The specific dosage you need is 992 mL of nitrogen mixed in a total volume of 1 liter.

Make sure to follow the instructions carefully to ensure you are using the correct amount. If you have any questions about how to use this medication or if you need further clarification, don’t hesitate to reach out to your healthcare provider for guidance.

What to Avoid

It's important to follow specific safety guidelines when using this product. Make sure you read and understand all safety precautions before handling it. Always use and store the product outdoors or in a well-ventilated area to ensure your safety. Additionally, only use equipment that is rated for the cylinder pressure, and remember to close the valve after each use and when the cylinder is empty.

To protect the product, keep it away from sunlight, especially when temperatures exceed 125°F (52°C). Following these instructions will help you use the product safely and effectively.

Side Effects

When using this product, it's important to be aware of potential serious side effects, including hypoxia (a condition where your body or a part of your body is deprived of adequate oxygen) and asphyxia (a severe lack of oxygen that can lead to suffocation). These conditions can occur if the product is not used correctly.

Generally, there are no common adverse reactions reported. However, remember that while nitrogen is typically safe when used as directed, improper use can lead to these serious health risks. Always ensure you follow the guidelines to minimize any potential dangers.

Warnings and Precautions

It's important to take certain precautions when using this product. Always use a backflow preventive device in the piping and ensure that you are using equipment that is rated for cylinder pressure. Additionally, protect the product from sunlight, especially when temperatures exceed 125°F (52°C). Before using, make sure to read and follow the Safety Data Sheet (SDS) for detailed safety information.

In case of overheating, immediately move the person to fresh air and ensure they are comfortable while breathing. Seek medical advice or attention if necessary. There are no specific laboratory tests required for this product, but staying informed and cautious is key to safe usage.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

There is currently no specific information available about the use of Nitrogen during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it is important to discuss any medications with your healthcare provider to ensure they are safe for you and your baby. Always prioritize open communication with your doctor regarding any concerns you may have about medications during this time.

Lactation Use

Currently, there is no specific information available regarding the use of Nitrogen for nursing mothers or its effects on breastfeeding. This means that if you are breastfeeding or planning to breastfeed, there are no established guidelines or known risks associated with this substance.

As always, it's important to consult with your healthcare provider about any medications or substances you may be considering while breastfeeding to ensure the safety of both you and your baby.

Pediatric Use

When it comes to using this medication in children, the information provided does not specifically address pediatric use. This means there are no recommended ages, dosage differences, or safety concerns outlined for children. As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication in younger patients. Always prioritize your child's safety and well-being by seeking expert advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safe use and storage of your product, always keep it outdoors or in a well-ventilated area. If the temperature rises above 52°C (125°F), make sure to protect it from direct sunlight to prevent any damage. After each use, remember to close the valve and when the product is empty, do the same to maintain safety.

Additionally, it's important to use a backflow preventive device in the piping to avoid any potential hazards. Only use this product with equipment that is rated for cylinder pressure to ensure safe operation. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Nitrogen, Compressed?

Nitrogen, Compressed is a gas under pressure, identified by UN Number UN1066.

What are the safety precautions for using Nitrogen, Compressed?

You should read all safety precautions before handling, use it outdoors or in a well-ventilated area, and ensure you use equipment rated for cylinder pressure.

What should I do if someone is exposed to heated Nitrogen, Compressed?

Remove the person to fresh air and keep them comfortable for breathing. Seek medical advice or attention.

What are the serious side effects of Nitrogen, Compressed?

Serious side effects include hypoxia (severe lack of oxygen) and asphyxia (severe suffocation).

Are there any common adverse reactions to Nitrogen, Compressed?

No common adverse reactions have been reported.

How should Nitrogen, Compressed be stored?

Store it outdoors or in a well-ventilated place, and protect it from sunlight when temperatures exceed 52°C (125°F).

Is there any information on the use of Nitrogen, Compressed during pregnancy?

The insert does not provide specific information regarding the use of Nitrogen during pregnancy.

What is the route of administration for Nitrogen, Compressed?

The route of administration is respiratory (inhalation).

What should I do after using Nitrogen, Compressed?

Close the valve after each use and when the cylinder is empty.

Who is the manufacturer of Nitrogen, Compressed?

The manufacturer is General Distributing Co., located at 430 17TH AVE NE, GREAT FALLS, MY 59403-2606.

Packaging Info

The table below lists all NDC Code configurations of Nitrogen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrogen.
Details

FDA Insert (PDF)

This is the full prescribing document for Nitrogen, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. The insert does not provide specific indications or usage information.

There are no documented teratogenic effects associated with this drug, nor are there any reported nonteratogenic effects. Healthcare professionals should consider the absence of these effects when evaluating the drug for patient use.

Dosage and Administration

The medication is administered via the respiratory route through inhalation. The recommended dosage is 992 mL of nitrogen in a total volume of 1 liter.

Healthcare professionals should ensure that the preparation is conducted in a controlled environment, adhering to safety protocols for handling gases. The inhalation should be performed using appropriate inhalation devices to ensure effective delivery to the respiratory system. Monitoring of the patient’s response during and after administration is advised to assess efficacy and safety.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following precautions to ensure safe use:

  • Handling should only occur after all safety precautions have been thoroughly read and understood.

  • The product must be used and stored exclusively outdoors or in a well-ventilated area to mitigate risks associated with inadequate ventilation.

  • Use is restricted to equipment that is rated for cylinder pressure to prevent potential hazards.

  • The valve should be closed after each use and when the cylinder is empty to avoid accidental release.

  • Protection from sunlight is necessary when ambient temperatures exceed 52°C (125°F) to prevent degradation or safety issues.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of the product.

Warnings The use of a backflow preventive device in the piping is essential to prevent potential hazards. Additionally, the product should only be utilized with equipment that is rated for cylinder pressure to avoid risks associated with overpressure. Care must be taken to protect the product from sunlight when ambient temperatures exceed 52°C (125°F), as exposure to high temperatures may compromise safety and efficacy.

General Precautions Prior to use, it is crucial to read and follow the Safety Data Sheet (SDS) to understand the handling, storage, and emergency measures associated with the product.

Emergency Medical Help Instructions In the event of heating, it is vital to remove the affected individual to fresh air and ensure they are comfortable for breathing. Immediate medical advice or attention should be sought to address any potential health concerns.

Stop Taking and Call Your Doctor Instructions Currently, there are no specific instructions regarding discontinuation of use or when to contact a healthcare provider. However, healthcare professionals should exercise clinical judgment based on individual patient circumstances.

Side Effects

Patients may experience serious adverse reactions, including severe hypoxia and severe asphyxia. These reactions are associated with improper use of the product. It is important to note that nitrogen, while an inert gas and generally considered safe when used as directed, can lead to these serious effects if misused.

No common adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Nitrogen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrogen.
Details

Pediatric Use

Pediatric use has not been specifically addressed in the available data. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific information.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Nitrogen during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. Given the absence of established risk categories or known fetal impacts, the potential benefits and risks should be carefully weighed in women of childbearing potential. It is advisable to counsel patients on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no information available regarding the use of Nitrogen in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this drug in lactating mothers and its potential impact on breastfed infants remain undetermined. Healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to safeguard the patient's health and well-being.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the ability to draw conclusions regarding the potential toxicological profile of the substance in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the product contains gas under pressure and may explode if heated. It is crucial to inform patients that the product may displace oxygen, potentially leading to rapid suffocation.

Patients should be instructed not to handle the product until they have read and understood all safety precautions. Emphasize the importance of using and storing the product only outdoors or in a well-ventilated area to minimize risks.

Healthcare providers should recommend the use of a backflow preventive device in the piping to ensure safety during use. It is essential to use the product only with equipment that is rated for cylinder pressure to prevent accidents. Patients should be reminded to close the valve after each use and when the cylinder is empty.

Additionally, patients should be cautioned to protect the product from sunlight when the ambient temperature exceeds 52°C (125°F). Encourage patients to read and follow the Safety Data Sheet (SDS) before use to ensure they are fully informed of the risks and safety measures.

In the event of exposure to heat, healthcare providers should instruct patients to remove the affected person to fresh air and keep them comfortable for breathing. It is important to seek medical advice or attention if any adverse effects occur.

Storage and Handling

The product is supplied in a manner that ensures safe handling and storage. It is essential to use and store the product exclusively outdoors or in a well-ventilated area to minimize risks associated with exposure.

When ambient temperatures exceed 52°C (125°F), the product must be protected from direct sunlight to prevent degradation or safety hazards. After each use, and when the product is empty, the valve should be securely closed to maintain safety and integrity.

Additionally, it is crucial to utilize a backflow preventive device in the piping to ensure proper functioning and safety. The equipment used with this product must be rated for cylinder pressure to guarantee safe operation.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by General Distributing Company. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nitrogen, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (NDA205891) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.