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Nitrogen

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This product has been discontinued

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
October 17, 2024
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
October 17, 2024
Manufacturer
Messer Canada Inc.
NDC root
52003-016
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 specialized product used primarily for analytical purposes, specifically in the assessment of nitrogen content in various materials. It has been validated by Messer as an acceptable alternative to the official methods for conducting nitrogen assays, ensuring reliable results for those who require precise measurements.

It's important to note that Nitrogen NF is not intended for human drug use, and its applications are strictly limited to laboratory and industrial settings. This means that while it plays a crucial role in quality control and analysis, it is not a medication or treatment for individuals.

Uses

This material is not approved for use as a drug in humans. Therefore, it is important to understand that it should not be used for any medical purposes.

Additionally, there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects) associated with this material. Always consult with a healthcare professional for safe and approved treatment options.

Dosage and Administration

To use this medication, you will inhale nitrogen gas through a respiratory (inhalation) method. The active ingredient in this treatment is nitrogen, and it comes in a strength of 995 mL in a 1-liter container.

Make sure to follow the instructions provided by your healthcare provider regarding how often you should use this inhalation therapy. It's important to use the medication as directed to ensure its effectiveness and your safety.

What to Avoid

It’s important to know that if the material is not delivered to a non-federal (NF) customer, it is considered “Not Approved for Human Drug Use.” This means you should not take or use this material under any circumstances. Always ensure that you are receiving approved products to safeguard your health.

Side Effects

It's important to note that if the material is not delivered to a designated customer, it is considered "Not Approved for Human Drug Use." This means that using it in any way for human health or treatment is not safe or authorized. Always ensure that any medical product you use is properly approved and delivered to the right recipient to avoid potential health risks.

Warnings and Precautions

It's important to know that if the material you receive is not delivered to a customer who is authorized (NF customer), it is considered "Not Approved for Human Drug Use." This means that it should not be used by people and could pose health risks.

If you have any concerns or experience unexpected effects after using a product, stop using it immediately and contact your doctor. Always prioritize your health and safety by ensuring that any medication or treatment you use is approved for human use.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

It’s important to know that this drug has not been approved by the FDA (U.S. Food and Drug Administration) for safety and effectiveness, which means it may not be safe for use during pregnancy. If you are pregnant or planning to become pregnant, you should be cautious and consult your healthcare provider before considering this medication.

Additionally, if the material is not delivered to a specific customer, it is labeled as “Not Approved for Human Drug Use.” This further emphasizes the need for careful consideration and professional guidance regarding its use during pregnancy. Always prioritize your health and the health of your baby by discussing any medications with your doctor.

Lactation Use

It’s important to know that this drug has not been approved by the FDA for safety and effectiveness, which means it may not be suitable for use during breastfeeding. If the product is not delivered to a customer who is a healthcare professional, it is considered “Not Approved for Human Drug Use.”

If you are breastfeeding or planning to breastfeed, it’s best to consult with your healthcare provider before using this medication to ensure the safety of both you and your baby.

Pediatric Use

It's important to know that this drug has not been approved by the FDA (Food and Drug Administration) for safety and effectiveness, which means it hasn't been confirmed as safe for use in children. If the material is not delivered to a specific customer type, it is considered "Not Approved for Human Drug Use."

As a parent or caregiver, you should be cautious and consult with a healthcare professional before considering this medication for your child, as it may not be suitable for them. Always prioritize FDA-approved treatments that have been proven safe and effective for pediatric use.

Geriatric Use

When it comes to using Nitrogen gas, there is no specific information available about how it affects older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you or a caregiver are considering this treatment, it’s important to consult with a healthcare professional who can provide personalized advice based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective use of any medical 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 standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to consider this when prescribing medications or adjusting dosages in the future. Regular check-ups and open communication are key to managing your health effectively.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

It’s important to handle and store the product correctly to ensure safety and effectiveness. If you receive this material and it is not delivered to a NF (Non-Food) customer, please note that it is “Not Approved for Human Drug Use.” This means it should not be used for any human applications.

Always keep the product in a safe, secure location and follow any specific storage instructions provided. If you have any questions about how to handle or dispose of the product safely, please consult the relevant guidelines or contact a professional for assistance.

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 postmarketing experiences related to this medication.

FAQ

What is Nitrogen NF?

Nitrogen NF is a drug that has a Certificate of Analysis and is validated by Messer as an acceptable alternative for Nitrogen Assay.

Is Nitrogen NF approved for human drug use?

No, Nitrogen NF is not approved for human drug use.

How is Nitrogen NF administered?

Nitrogen NF is administered via respiratory inhalation.

What is the strength of Nitrogen NF?

The strength of Nitrogen NF is 995 mL in 1 L.

Are there any teratogenic effects associated with Nitrogen NF?

No teratogenic effects are mentioned for Nitrogen NF.

What precautions should be taken with Nitrogen NF?

You should ensure that the material is delivered to a NF customer, as it is not approved for human drug use.

What are the warnings associated with Nitrogen NF?

The main warning is that if the material is not delivered to a NF customer, it is not approved for human drug use.

Is there any information on drug interactions with Nitrogen NF?

No drug interactions have been found in the provided text.

What should I know about the FDA's stance on Nitrogen NF?

The FDA has not found Nitrogen NF to be safe and effective, and this labeling has not been approved by the FDA.

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

Nitrogen NF is a high-purity nitrogen product with a minimum nitrogen content exceeding 99.0%, as specified by Messer, which maintains a more stringent specification of greater than 99.999%. The product is characterized by the absence of odor and contains oxygen levels below 10,000 parts per million (ppm), with Messer's specification being less than 5.0 ppm. Carbon monoxide levels are maintained below 10.0 ppm. The product does not contain detectable levels of tetrahydrocannabinol (THC), water (H2O), carbon dioxide (CO2), or hydrogen (H2).

This analyzer has undergone validation by Messer, confirming its acceptability as an alternative to the official NF for Nitrogen Assay. Documentation of the validation study is retained at Messer's corporate offices. It is important to note that if the material is not delivered to a customer requiring NF specifications, it is classified as "Not Approved for Human Drug Use."

Uses and Indications

This drug is indicated for research purposes only and is not approved for human drug use. There are no reported teratogenic or nonteratogenic effects associated with this material.

Dosage and Administration

The active ingredient, nitrogen, is to be administered via inhalation. The recommended strength is 995 mL of nitrogen in a 1 L volume.

Healthcare professionals should ensure that the administration is performed using appropriate inhalation techniques to facilitate effective delivery of the gas. It is essential to monitor the patient during the inhalation process to ensure proper absorption and to assess for any adverse reactions.

Contraindications

The material is contraindicated for use in humans if it is not delivered to a non-federal (NF) customer, as it is classified as “Not Approved for Human Drug Use.”

Warnings and Precautions

The material is strictly designated for use by NF customers. In instances where the material is not delivered to an NF customer, it is classified as “Not Approved for Human Drug Use.”

Healthcare professionals must ensure that the material is utilized in accordance with this designation to prevent any potential misuse or adverse effects associated with unapproved applications. It is imperative to adhere to this guideline to maintain compliance with regulatory standards and ensure patient 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 warning highlights the importance of ensuring proper delivery to designated recipients to avoid any potential misuse or adverse effects associated with unapproved substances.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences, as the material's use is restricted to approved conditions. Therefore, healthcare professionals should exercise caution and ensure compliance with the delivery requirements to mitigate any risks associated with the use of this material.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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

This drug has not been found by the FDA to be safe and effective for pediatric use, and this labeling has not been approved by the FDA. Consequently, the material is considered “Not Approved for Human Drug Use” if it is not delivered to a non-federal (NF) customer. Therefore, healthcare professionals should exercise caution when considering this drug for pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of Nitrogen gas, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when considering the administration of this agent to geriatric patients.

Due to the absence of detailed guidance, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or complications that may arise during treatment. Individual patient assessment and clinical judgment should guide the decision-making process in this population.

Pregnancy

This drug has not been found by the FDA to be safe and effective for use during pregnancy, and this labeling has not been approved by the FDA. Therefore, it is classified as “Not Approved for Human Drug Use.” Healthcare professionals should exercise caution when considering this drug for pregnant patients, as the potential risks to fetal outcomes are not well characterized due to the lack of approved indications and safety data. It is recommended that women of childbearing potential discuss alternative treatment options with their healthcare provider to ensure the safety of both the patient and the fetus.

Lactation

This drug has not been found by the FDA to be safe and effective for use in lactating mothers, and this labeling has not been approved by the FDA. Consequently, the material is considered “Not Approved for Human Drug Use.” There is no available data on excretion in breast milk or effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider alternative treatments when advising lactating 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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for effective treatment and follow-up care.

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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience indicates that this drug has not been found by the FDA to be safe and effective, and the labeling has not received FDA approval. Additionally, it is noted that if the material is not delivered to a non-FDA customer, it is classified as “Not Approved for Human Drug Use.”

Patient Counseling

Healthcare providers should advise patients that if the material is not delivered to a non-federal (NF) customer, it is considered “Not Approved for Human Drug Use.” It is important for patients to understand the implications of this designation and to seek clarification on any questions they may have regarding the use of the material. Providers should ensure that patients are aware of the potential risks associated with using materials that are not approved for human consumption.

Storage and Handling

The material is supplied with specific conditions for handling and storage. It is essential to note that if the material is not delivered to a NF customer, it is classified as “Not Approved for Human Drug Use.”

Proper storage conditions must be adhered to, ensuring that the material is maintained in a suitable environment to preserve its integrity. Specific temperature ranges and container requirements should be followed, although these details are not provided in the current information. Special handling needs may also apply, and it is crucial for healthcare professionals to be aware of these requirements to ensure safe and effective use of the material.

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 Canada 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 () 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.