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Nitrogen

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Active ingredient
Nitrogen 995 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 1960
Label revision date
November 18, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrogen 995 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 1960
Label revision date
November 18, 2025
Manufacturer
Messer Gas Puerto Rico, Inc
Registration number
NDA205816
NDC root
52374-016
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Nitrogen, NF is a medical gas that is supplied in cylinders or vessels and is certified to meet specific standards for quality and safety. It is primarily used in various medical applications, ensuring compliance with regulations set by the FDA. The gas is manufactured following strict guidelines to guarantee its purity, with an assay of at least 99.0% nitrogen content and minimal levels of impurities such as oxygen and carbon monoxide.

This certification helps you ensure that the nitrogen you are using meets the necessary regulatory requirements for medical use. However, it's important to note that these cylinders are not intended for instrument calibration purposes.

Uses

It appears that there are no specific uses or indications provided for this drug. This means that the information available does not outline any particular conditions or situations for which the drug is intended.

Additionally, there are no details regarding teratogenic effects (which refer to potential harm to a developing fetus) or any nonteratogenic effects. This lack of information suggests that the drug's safety profile in these areas has not been established or reported. If you have any concerns or questions about this drug, it's best to consult with a healthcare professional for more personalized guidance.

Dosage and Administration

You will be using a medication that is administered through inhalation, which means you will breathe it in. The active ingredient in this medication is nitrogen, and it comes in a concentration of 995 mL per 1 liter.

This medication is packaged in a large tank that holds 25,000 liters, so it’s designed for significant use. Make sure to follow your healthcare provider's instructions on how to use this inhalation therapy properly to ensure you get the most benefit from it.

What to Avoid

It’s important to know that this material is not approved for human drug use. Therefore, you should not take or use it under any circumstances. This means that it has not been tested or deemed safe for people, and using it could pose serious health risks. Always prioritize your safety and consult with a healthcare professional if you have questions about medications or treatments.

Side Effects

It's important to note that the material discussed is not approved for human drug use. This means that if it is not delivered to a specific customer type (referred to as NF customers), it should not be used by people. Always ensure that any medication or treatment you consider is appropriate and approved for human use.

Warnings and Precautions

It's important to note that the material you are using is "Not Approved for Human Drug Use" unless it is delivered to a qualified customer. This means you should not use it for any human applications.

To ensure safety and compliance, you must adhere to specific regulations, including 21 CFR 211.84, which relates to the quality of materials. Additionally, if you are using cylinders and vessels filled from these supply cylinders, you are required to conduct finished product testing according to 21 CFR 211.265. Remember, these cylinders are not certified for instrument calibration purposes, so be cautious in their application.

While there are no specific emergency instructions or directives to stop use and call your doctor mentioned, always prioritize your safety and consult a healthcare professional if you have any concerns or experience unexpected issues.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember, when in doubt, it’s better to be safe and get help right away.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how the medication may affect you or your baby during this time. Additionally, there are no recommended dosage changes for pregnant individuals, nor are there any special precautions outlined for use while pregnant.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before starting any new medication. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage adjustments, or safety guidelines specifically for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is safe and appropriate for their individual needs. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 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 storage and handling of the product, please follow the Standard Operating Procedures used for the manufacture of Medical Gases. It's important to comply with the FDA’s Current Good Manufacturing Practices (cGMP) Regulations and the FDA Medical Gas Guidelines to maintain safety and effectiveness.

Keep in mind that these cylinders are not certified for instrument calibration purposes. Additionally, if the material is not delivered to a customer who is a part of the National Fire (NF) safety standards, it is considered “Not Approved for Human Drug Use.” Always handle the product with care and follow these guidelines to ensure safety.

Additional Information

You will use this medication through inhalation, which means you will breathe it in to receive the treatment. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market.

FAQ

What is Nitrogen, NF?

Nitrogen, NF is a medical gas supplied in cylinders/vessels, certified for compliance with specific regulations.

How is Nitrogen, NF manufactured?

The cylinders are filled according to Standard Operating Procedures and comply with FDA’s Current Good Manufacturing Practices (cGMP) and Medical Gas Guidelines.

What are the key specifications for Nitrogen, NF?

Nitrogen, NF must pass tests for identification, odor, oxygen content, carbon monoxide levels, and assay, with an assay of at least 99.0%.

What is the route of administration for Nitrogen, NF?

Nitrogen, NF is administered via respiratory (inhalation) route.

Is Nitrogen, NF approved for human drug use?

No, Nitrogen, NF is not approved for human drug use and should only be delivered to NF customers.

What precautions should be taken when using Nitrogen, NF?

Ensure compliance with 21 CFR 211.84 and other relevant regulations, as the certification does not eliminate your obligations under these laws.

Are there any specific instructions for the use of Nitrogen, NF?

You should follow FDA’s cGMP Regulations and Medical Gas Guidelines when using Nitrogen, NF.

What should I do in case of an emergency with Nitrogen, NF?

Emergency medical help instructions are not specified in the provided text.

Is there any information regarding the use of Nitrogen, NF during pregnancy or lactation?

The document does not provide specific information regarding the use of Nitrogen, NF during pregnancy or lactation.

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 not associated with any specific indications or usage information as per the available documentation. There are no reported teratogenic effects or potential fetal harm related to this drug. Additionally, the documentation does not provide any information regarding nonteratogenic effects or statements indicating no fetal harm. Therefore, healthcare professionals should exercise caution and consider the lack of detailed indications and usage information when prescribing this drug.

Dosage and Administration

The active ingredient in this formulation is nitrogen, provided at a strength of 995 mL per 1 L. The recommended route of administration is via inhalation.

Healthcare professionals should ensure that the nitrogen is delivered using appropriate respiratory equipment designed for inhalation therapy. The product is packaged in a tank containing 25,000 L of nitrogen, identified by the item code NDC: 52374-016.

It is essential to follow established protocols for the safe handling and administration of inhaled gases, ensuring that the delivery system is functioning correctly and that the patient is monitored throughout the inhalation process.

Contraindications

The material is contraindicated for use in humans as it is “Not Approved for Human Drug Use.” This restriction is in place due to the lack of safety and efficacy data for human applications.

Warnings and Precautions

The material is designated as “Not Approved for Human Drug Use” if it is not delivered to a NF customer. This classification underscores the importance of adhering to regulatory standards to ensure safety and compliance.

To facilitate compliance with regulatory requirements, the vendor provides a certification to the customer. This certification serves as a tool to assist the customer in meeting the obligations outlined in 21 CFR 211.84. However, it is crucial to note that this certification does not absolve the customer from the responsibility of complying with other relevant sections of 21 CFR 210 and 211. Specifically, adherence to 21 CFR 211.265, which pertains to finished product testing for cylinders and vessels filled from these supply cylinders, is mandatory. Furthermore, it is important to recognize that these cylinders are not certified for instrument calibration purposes.

Healthcare professionals are advised to ensure compliance with 21 CFR 211.84, which necessitates appropriate laboratory testing. Additionally, finished product testing in accordance with 21 CFR 211.265 is required for any cylinders and vessels filled from the supply cylinders to guarantee product integrity and safety.

Side Effects

Patients should be aware that the material is “Not Approved for Human Drug Use” if it is not delivered to a NF customer. This caution highlights the importance of ensuring that the material is handled and distributed appropriately to avoid any potential adverse reactions associated with unapproved usage.

As there are no specific adverse reactions listed beyond this caution, it is essential for healthcare providers to monitor patients closely for any unexpected effects should the material be used outside of its intended approval.

Drug Interactions

There are currently no documented drug interactions associated with 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

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this medication during pregnancy. Currently, there are no documented safety concerns associated with its use in this population. Additionally, there are no dosage modifications recommended for pregnant patients, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and a detailed history of substance use.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

  4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

It is imperative for healthcare professionals to familiarize themselves with the specific antidotes or treatment protocols relevant to the substance in question, as these may significantly influence patient outcomes in cases of overdose.

Nonclinical Toxicology

The material is classified as "Not Approved for Human Drug Use" if it is not delivered to a NF customer, indicating potential teratogenic effects. No additional information regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology is available.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should inform patients that if the material is not delivered to a non-federal (NF) customer, it is classified as “Not Approved for Human Drug Use.” It is essential for patients to understand the implications of this classification and the importance of ensuring that the material is handled appropriately. Providers should encourage patients to ask questions if they have any concerns regarding the use or delivery of the material.

Storage and Handling

The product is supplied in accordance with the Standard Operating Procedures utilized for the manufacture of Medical Gases. It is essential to ensure compliance with the FDA’s Current Good Manufacturing Practices (cGMP) Regulations and the FDA Medical Gas Guidelines during storage and handling.

These cylinders are not certified for instrument calibration purposes. Additionally, it is important to note that if the material is not delivered to a NF customer, it is classified as “Not Approved for Human Drug Use.”

Additional Clinical Information

The route of administration for the medication is via respiratory inhalation. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrogen as submitted by Messer Gas Puerto Rico, 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 (NDA205816) 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

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.