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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
October 30, 2025
FDA Insert
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
October 30, 2025
Manufacturer
Andy-Oxy Co. , Inc.
Registration number
NDA205766
NDC root
50063-002
FDA Insert
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Nitrogen is a refrigerated liquid non-flammable gas that is primarily used in various medical and industrial applications. It is important to note that the administration of nitrogen should only be performed by or under the supervision of a licensed practitioner who is experienced in its use.

This gas is utilized in settings where its unique properties can be beneficial, such as in cryogenic applications or as an inert atmosphere for certain processes. Due to its extremely cold nature, proper handling and safety precautions are essential to prevent hazards like frostbite or suffocation.

Uses

You should be aware that the administration of nitrogen can be risky and is not suitable for everyone. It is essential that this treatment is only given by a licensed healthcare professional who has experience with nitrogen. They will understand the proper uses, effects, dosages, and methods of administration, as well as any potential hazards or side effects.

There are no specific teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with nitrogen. However, always consult with your healthcare provider for personalized advice and to ensure safe use.

Dosage and Administration

It's important to know that this medication should only be used by you or under the supervision of a licensed healthcare professional who has experience with nitrogen. Before using it, your healthcare provider will ensure that you understand the reasons for its use, how it works, the correct dosages, and the methods for taking it.

You will be using this medication through inhalation (breathing it in), which allows it to enter your respiratory system directly. The active ingredient in this medication is nitrogen, with a concentration of 992 mL in every liter. Your healthcare provider will guide you on how often and for how long you should use it, ensuring that you receive the right care throughout your treatment.

What to Avoid

It's important to follow specific guidelines to ensure your safety when using this product. First, make sure to read and understand all safety precautions before handling it. Always use and store the product outdoors or in a well-ventilated area to avoid any potential hazards. Additionally, only use equipment that is rated for the cylinder pressure to prevent accidents.

After each use, remember to close the valve, especially when the cylinder is empty. To protect the product, keep it out of direct sunlight, particularly when temperatures exceed 125°F (52°C). By adhering to these instructions, you can help ensure a safe experience.

Side Effects

Using this product comes with important safety considerations. It may displace oxygen, which can lead to rapid suffocation if not handled properly. To ensure your safety, it’s crucial to read and understand all safety precautions before use. Always use and store the product outdoors or in a well-ventilated area, and make sure to use equipment that is rated for the cylinder pressure.

Additionally, remember to close the valve after each use and when the cylinder is empty. Protect the product from sunlight, especially when temperatures exceed 125°F (52°C). Following these guidelines will help minimize risks associated with its use.

Warnings and Precautions

It's important to handle nitrogen safely to avoid serious risks. Always keep the container upright and be aware that the liquid and gas are extremely cold and under pressure, which can lead to rapid suffocation or severe frostbite. Only use nitrogen under the supervision of a licensed practitioner who understands its proper use and potential hazards. Make sure to read all safety precautions before handling.

When using nitrogen, ensure you are in a well-ventilated area and use equipment specifically designed for nitrogen service. Avoid contact with skin, eyes, or clothing, and wear protective gear like gloves and a face shield when withdrawing liquid. Never drop the cylinder, and always close the valve after use. If you need to enter a confined space where nitrogen gas may be present, ensure the area is well-ventilated and tested for adequate oxygen levels.

If you inhale nitrogen, move to fresh air immediately and seek medical help if breathing is difficult. In case of frostbite, seek medical treatment right away. Always prioritize safety and follow the guidelines provided.

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 an overdose. These 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

Using Nitrogen during pregnancy can be risky, and it is important to approach its use with caution. You should only consider this treatment under the guidance of a licensed healthcare professional who has experience with Nitrogen. This expert will be knowledgeable about the appropriate dosages, methods of administration, and potential side effects, as well as the specific risks and contraindications (situations where the treatment should not be used).

If you are pregnant or planning to become pregnant, it is crucial to discuss any potential treatments with your healthcare provider to ensure the safety of both you and your baby. Always prioritize open communication with your medical team regarding any concerns or questions you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

When considering the use of nitrogen for children, it's important to be aware that its administration can be risky and is not recommended without the guidance of a qualified healthcare professional. This means that only a licensed practitioner who has experience with nitrogen should oversee its use in children. They will understand the specific reasons for using it, how to give it safely, the correct dosages, and any potential side effects or precautions that need to be taken.

If you are a parent or caregiver, ensure that any treatment involving nitrogen is closely monitored by a healthcare provider who is knowledgeable about its use in children. This will help ensure the safety and well-being of your child during treatment.

Geriatric Use

While there is no specific information about the use of Nitrogen in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting treatment. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 related to 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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 your safety and the proper use of the product, always keep the container in an upright position and store it in a well-ventilated area, preferably outdoors. When handling the product, use equipment specifically designed for Nitrogen service that can handle the cylinder's pressure. If you need to withdraw liquid, make sure to wear a face shield and gloves for protection.

Avoid dropping the container; instead, use a hand truck designed for moving liquid cylinders. After each use, close the valve, especially when the cylinder is empty. Never vent the cylinder in a confined space, and protect it from sunlight if the temperature exceeds 52°C (125°F). Following these guidelines will help ensure safe handling and storage.

Additional Information

You will be using this medication through inhalation, which means you will breathe it in. It's important to note that the administration of nitrogen can be dangerous or not recommended for everyone. Therefore, you should only use this medication under the guidance of a licensed healthcare professional who has experience with nitrogen. This professional will be knowledgeable about how to use it safely, including the correct dosages, methods, and any potential risks or side effects. Always follow their instructions carefully to ensure your safety.

FAQ

What is Nitrogen?

Nitrogen is a refrigerated liquid non-flammable gas used under the supervision of a licensed practitioner experienced in its administration.

What precautions should I take when using Nitrogen?

Always keep the container in an upright position, store and use with adequate ventilation, and do not get liquid in your eyes, on your skin, or clothing.

What should I do in case of inhalation of Nitrogen?

If inhaled, remove the person to fresh air, provide artificial respiration if not breathing, and call a physician.

Is there any risk of suffocation with Nitrogen?

Yes, Nitrogen may displace oxygen and cause rapid suffocation; it should be used with caution.

Can I use Nitrogen without supervision?

No, Nitrogen should only be used by or under the supervision of a licensed practitioner familiar with its administration.

What should I do if I experience frostbite from Nitrogen?

In case of frostbite, obtain medical treatment immediately.

Are there any specific storage instructions for Nitrogen?

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

What is the route of administration for Nitrogen?

The route of administration for Nitrogen is respiratory (inhalation).

What should I do after using Nitrogen?

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

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 drug.

Uses and Indications

This drug is indicated for use in specific medical situations where the administration of nitrogen is deemed necessary. It is essential that this drug be administered only by or under the supervision of a licensed practitioner who possesses experience in the use and administration of nitrogen. The practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, and duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Limitations of use include the potential hazards associated with nitrogen administration, which may render it contraindicated in certain circumstances. There are no specific teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Administration of nitrogen is to be conducted exclusively by or under the supervision of a licensed practitioner experienced in its use and administration. Healthcare professionals must possess a thorough understanding of the indications, effects, dosages, methods, frequency, and duration of administration prior to initiating treatment.

The route of administration for nitrogen is via respiratory inhalation. The active ingredient consists of nitrogen at a concentration of 992 mL in 1 L. It is imperative that practitioners adhere to established protocols for inhalation to ensure safe and effective delivery of the gas.

Contraindications

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

  • Do not handle the product until all safety precautions have been read and understood.

  • Use and store the product only outdoors or in a well-ventilated area to minimize the risk of exposure to harmful vapors.

  • Utilize equipment that is rated for cylinder pressure to prevent equipment failure and potential hazards.

  • Ensure the valve is closed after each use and when the cylinder is empty to prevent leaks.

  • Protect the product from sunlight when ambient temperatures exceed 52°C (125°F) to avoid degradation or potential hazards.

Warnings and Precautions

The container must always be kept in an upright position to prevent accidental release of gas. The liquid and gas are extremely cold and under pressure, posing risks of rapid suffocation and severe frostbite. The administration of nitrogen is potentially hazardous or contraindicated; it should only be performed by or under the supervision of a licensed practitioner who possesses expertise in the use and administration of nitrogen. This includes familiarity with the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

It is critical to note that the product contains gas under pressure, which may explode if heated. Additionally, it can displace oxygen, leading to rapid suffocation. Therefore, it is imperative that all safety precautions are thoroughly read and understood before handling the product.

General precautions include ensuring adequate ventilation during storage and use. Equipment designated for nitrogen service and rated for cylinder pressure should be utilized exclusively. Care must be taken to avoid contact with liquid nitrogen, as it can cause severe injury if it comes into contact with eyes, skin, or clothing. When withdrawing liquid nitrogen, appropriate personal protective equipment, including a face shield and gloves, should be worn.

Cylinders should not be dropped; instead, a hand truck specifically designed for liquid cylinder movement should be used. The valve must be closed after each use and when the cylinder is empty. Venting of the cylinder in confined spaces is strictly prohibited. Entry into confined spaces where gas may be present should only occur after ensuring the area has been adequately ventilated and tested for sufficient oxygen levels (at least 19%) using an approved oxygen measuring instrument. Alternatively, personnel should wear an approved air-supplied breathing apparatus, with a second person present and similarly equipped. Protection from sunlight is necessary when ambient temperatures exceed 52°C (125°F). Prior to use, the Safety Data Sheet (SDS) should be read and followed.

In the event of inhalation, the individual should be removed to fresh air. If breathing has ceased, artificial respiration should be administered. If breathing is difficult, oxygen should be provided, and medical assistance should be sought immediately. If frostbite occurs, it is essential to obtain medical treatment without delay.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this product. Notably, it may displace oxygen and cause rapid suffocation, which underscores the importance of adhering to safety precautions.

Participants are advised to handle the product only after thoroughly reading and understanding all safety guidelines. It is crucial to use and store the product exclusively outdoors or in a well-ventilated area to mitigate risks. Additionally, a backflow preventive device should be employed in the piping to ensure safety during use.

Furthermore, it is essential to utilize equipment that is rated for cylinder pressure and to close the valve after each use and when the cylinder is empty. To prevent potential hazards, the product should be protected from sunlight when ambient temperatures exceed 52°C (125°F). These precautions are vital to ensure the safety of patients and to minimize the risk of adverse reactions.

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

Administration of nitrogen in pediatric patients may pose significant risks and is contraindicated in certain situations. It is essential that nitrogen is used only by or under the supervision of a licensed practitioner who possesses experience in its administration. This practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions. Careful consideration and adherence to these guidelines are critical to ensure the safety and efficacy of nitrogen use in children.

Geriatric Use

There is no specific information regarding the use of Nitrogen in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or changes in response to treatment is advisable in this population.

Pregnancy

The administration of Nitrogen during pregnancy may pose potential risks and is considered hazardous or contraindicated. Pregnant patients should only receive Nitrogen under the supervision of a licensed practitioner who is experienced in its use and administration. This practitioner must be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Due to the lack of comprehensive data on the effects of Nitrogen on fetal outcomes, healthcare professionals are advised to carefully weigh the potential benefits against the risks when considering its use in pregnant patients. It is essential to ensure that any administration is conducted in a controlled environment, with appropriate monitoring and support in place.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to monitor breastfed infants for any potential adverse effects if the medication is administered to nursing mothers.

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 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 indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant clinical guidelines for specific management protocols tailored to the substance involved.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to always keep the container in an upright position to prevent accidents. It is important to communicate that the liquid and gas are extremely cold and under pressure, which can lead to rapid suffocation and severe frostbite if mishandled.

Patients should be instructed to store and use the product in areas with adequate ventilation. They must only use equipment that is specifically designated for Nitrogen service and rated for the cylinder pressure. Emphasize the importance of avoiding contact with the liquid, as it should not get into the eyes, on the skin, or on clothing. When withdrawing liquid, patients should wear a face shield and gloves to protect themselves.

Providers should caution patients against dropping the cylinder and recommend using a hand truck designed specifically for the movement of liquid cylinders. It is essential to close the valve after each use and when the cylinder is empty. Patients should be reminded to use the product in accordance with the Material Safety Data Sheet (MSDS) and to avoid venting the cylinder in confined spaces.

Additionally, patients should be informed that they should not enter confined spaces where gas may be present unless the area has been well-ventilated and tested for adequate oxygen levels (at least 19%) using an approved oxygen measuring instrument. If necessary, they should wear an approved air-supplied breathing apparatus and ensure that a second person is present and similarly equipped.

Healthcare providers must stress that the administration of Nitrogen may be hazardous or contraindicated and should only be performed by or under the supervision of a licensed practitioner experienced in its use. This practitioner should be familiar with the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

Patients should be made aware that this product is available by prescription only, as federal law prohibits dispensing without a prescription. In case of an emergency, if the product is inhaled, patients should be removed to fresh air. If breathing has stopped, artificial respiration should be administered, and if breathing is difficult, oxygen should be provided. It is crucial to call a physician in such situations. In the event of frostbite, patients should seek medical treatment immediately.

Storage and Handling

The product is supplied in containers that must always be kept in an upright position. It is essential to store and use the product in areas with adequate ventilation to ensure safety. Equipment designated for Nitrogen service and rated for cylinder pressure should be utilized exclusively with this product.

For liquid withdrawal, appropriate personal protective equipment, including a face shield and gloves, is required. Care should be taken to avoid dropping the container; a hand truck specifically designed for liquid cylinder movement should be used for transport. After each use and when the container is empty, the valve must be closed to prevent any accidental release.

It is critical to avoid venting the cylinder in confined spaces. Additionally, when ambient temperatures exceed 52°C (125°F), the container should be protected from direct sunlight. The product should only be used and stored outdoors or in a well-ventilated area to maintain safety and efficacy.

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. Clinicians should be aware that the administration of nitrogen may pose hazards or be contraindicated. It is essential that this medication is used only by or under the supervision of a licensed practitioner who is experienced in its use. This practitioner should be knowledgeable about the indications, effects, dosages, methods, frequency, duration of administration, as well as the associated hazards, contraindications, side effects, and necessary precautions.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Andy-Oxy Co. , Inc.. 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 (NDA205766) 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.

Learn more in our Editorial Policy

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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.