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Nitrogen

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Active ingredient
Nitrogen 99 L/100 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
January 16, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrogen 99 L/100 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
January 16, 2025
Manufacturer
Air Liquide Large Industries U. S. LP
Registration number
NDA205738
NDC root
11853-023
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 N.F. is a medical-grade nitrogen gas produced by Air Liquide large Industries U.S. L.P. in Houston, TX. It is specifically designed for use in medical applications and is available only to medical customers who are properly registered with the FDA. This ensures that the nitrogen is used safely and effectively in various healthcare settings.

Nitrogen is created through a process called air liquefaction, which separates nitrogen from other gases in the air. In medical contexts, nitrogen can be utilized for a variety of purposes, including as a cryogenic agent for preserving biological samples or in certain medical procedures.

Uses

You should know that this product is intended for use in specific medical applications and is only available to medical professionals who are properly registered with the FDA. This means that it is not for general consumer use and should only be handled by qualified individuals in a medical setting.

Additionally, there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This information is important for understanding the safety profile of the drug in medical contexts.

Dosage and Administration

You will use this medication through inhalation, which means you will breathe it in. Specifically, you will inhale nitrogen gas as needed for your medical treatment. It's important to follow your healthcare provider's instructions on how often to use it, ensuring you get the right amount for your needs. Always make sure to use the medication as directed to achieve the best results for your health.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication as per the provided information. Therefore, you do not need to worry about any particular "do not take" or "do not use" instructions related to this drug. Always consult your healthcare provider for personalized advice and guidance regarding your medication.

Side Effects

There are no specific adverse reactions or side effects associated with nitrogen gas when used in a medical context. It's important to note that this information applies only to medical applications and should be used by healthcare professionals who are properly registered with the FDA. If you have any concerns or questions about its use, it's best to consult with your healthcare provider.

Warnings and Precautions

When using this product, it's important to note that it is intended for medical applications only and should be used by individuals or organizations that are properly registered with the FDA. Before you proceed, make sure that you are using the most current version of the form, as completed forms are permanent records and must be kept according to the record retention policy.

There are no specific laboratory tests required for safe use, and no emergency medical help instructions or directives to stop use and contact your doctor are provided. Always ensure you are following the guidelines and using the product as intended.

Overdose

If you suspect an overdose, it's important to act quickly. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely action can make a significant difference.

Pregnancy Use

While the provided information does not specify any particular safety concerns, dosage modifications, or special precautions for use during pregnancy, it's always important to consult with your healthcare provider if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and any medications you may be taking. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of Nitrogen in nursing mothers or its effects on lactation (the process of producing breast milk). Since the drug insert does not address this topic, it’s advisable to consult your healthcare provider for personalized guidance and to discuss any potential risks or concerns related to breastfeeding while using this medication. Your healthcare provider can help you make informed decisions that prioritize both your health and your baby's well-being.

Pediatric Use

When considering this medication for your child, it's important to know that it is intended for use in specific medical situations and should only be administered by healthcare professionals who are properly registered with the FDA (Food and Drug Administration). This ensures that the medication is used safely and effectively in children. Always consult with your child's doctor to understand the appropriate use and any potential risks involved.

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, especially if you or a loved one is elderly. Since the drug insert does not mention dosage adjustments or safety concerns for this age group, it’s advisable to consult with a healthcare provider before starting treatment. They can help ensure that the medication is appropriate and safe based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to address any questions or concerns.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no known 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 start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of the product, store it in a well-ventilated area and keep the container tightly closed to prevent contamination. It's important to protect the container from physical damage, as this can compromise the product's integrity.

When handling the product, always use appropriate personal protective equipment (such as gloves or masks) to safeguard yourself. Finally, remember to dispose of any unused or expired product according to your local regulations to ensure safe and responsible waste management.

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, or patient counseling information.

FAQ

What is AIR LIQUIDE NITROGEN N.F.?

AIR LIQUIDE NITROGEN N.F. is a nitrogen product produced by Air Liquide large Industries U.S. L.P. in Houston, TX.

How is AIR LIQUIDE NITROGEN N.F. administered?

It is administered via respiratory inhalation as required for medical applications.

What are the indications for using AIR LIQUIDE NITROGEN N.F.?

N.F. applies only when used in a medical application or by medical customers properly registered with the FDA.

Are there any teratogenic effects associated with AIR LIQUIDE NITROGEN N.F.?

No teratogenic effects are mentioned for AIR LIQUIDE NITROGEN N.F.

What precautions should I take when using AIR LIQUIDE NITROGEN N.F.?

Ensure that you are using the current revision of the form and that it is used in a medical application by registered customers.

Are there any adverse reactions associated with AIR LIQUIDE NITROGEN N.F.?

No specific adverse reactions or side effects are listed for Nitrogen gas.

How should AIR LIQUIDE NITROGEN N.F. be stored?

Store in a well-ventilated area, keep the container tightly closed, and protect it from physical damage.

Is there any information regarding the use of AIR LIQUIDE NITROGEN N.F. during pregnancy?

The text does not provide specific information regarding the use of AIR LIQUIDE NITROGEN N.F. during pregnancy.

What should I do in case of an emergency while using AIR LIQUIDE NITROGEN N.F.?

No specific instructions for getting emergency medical help are mentioned in the provided text.

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

AIR LIQUIDE NITROGEN N.F. is produced by Air Liquide Large Industries U.S. L.P., located in Houston, TX 77056. This product is designated with Form Number 2A-ALL-QUA-0003-F and is currently at Revision 0, effective as of March 2, 2006. The designation "N.F." applies exclusively when the product is utilized in medical applications or by medical customers who are properly registered with the FDA.

Uses and Indications

This drug is indicated for use in medical applications by healthcare professionals who are properly registered with the FDA.

Limitations of Use: The drug is not indicated for use outside of medical applications or by individuals who are not registered medical customers.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication is administered via inhalation of nitrogen gas, as required for specific medical applications. Healthcare professionals should ensure that the inhalation technique is appropriate for the patient and that the dosage is tailored to the individual needs of the patient. Monitoring of the patient's response to the treatment is essential to determine the frequency and duration of administration.

Contraindications

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

Warnings and Precautions

N.F. is indicated solely for use in medical applications by healthcare professionals who are properly registered with the FDA. It is imperative that users ensure compliance with this requirement to maintain safety and efficacy.

Users must verify that the version of the form being utilized is the most current revision prior to its application. It is important to note that completed forms are considered permanent records and are subject to the institution's record retention policy. This ensures that all documentation remains accurate and accessible for future reference.

Currently, there are no specific laboratory tests required or recommended for the safe use of N.F. Therefore, healthcare professionals should remain vigilant and adhere to general clinical guidelines when administering this product.

At this time, there are no explicit instructions provided regarding the need to seek emergency medical assistance or to discontinue use and consult a physician. Healthcare providers should exercise their clinical judgment and follow standard protocols in the event of any adverse reactions or concerns.

Side Effects

In the context of Nitrogen gas, no specific adverse reactions or side effects have been identified in the available data. It is important to note that the designation of N.F. (National Formulary) applies exclusively when Nitrogen gas is utilized in a medical application or by medical customers who are properly registered with the FDA. As such, the absence of documented adverse reactions underscores the necessity for adherence to regulatory guidelines and proper usage protocols in medical settings.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

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 patients may only use N.F. in a medical context, and it is essential that it is administered by medical customers who are properly registered with the FDA. This ensures compliance with regulatory standards and safety protocols specific to pediatric use.

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 monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to initiating treatment.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been identified in the available data. There are no dosage modifications recommended for pregnant patients, nor are there any special precautions indicated for use during pregnancy. Healthcare professionals should continue to monitor the latest research and guidelines to ensure the safety and efficacy of this medication in pregnant patients.

Lactation

There is no information available regarding the use of Nitrogen in nursing mothers or any lactation considerations. Consequently, the effects on breastfed infants and the excretion of Nitrogen in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers.

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.

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.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that N.F. is intended for use solely in medical applications and must be utilized by medical customers who are properly registered with the FDA. It is important for patients to understand the significance of this registration and the implications of using N.F. outside of the specified medical context. Providers should ensure that patients are aware of the necessity of adhering to these guidelines to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a well-ventilated area, ensuring that the container remains tightly closed to maintain integrity. It is essential to protect the product from physical damage during storage and handling. When handling the product, appropriate personal protective equipment should be utilized to ensure safety. Disposal of the product must be conducted in accordance with local regulations to comply with environmental and safety standards.

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 Air Liquide Large Industries U. S. LP. 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 (NDA205738) 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.