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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 2007
Label revision date
October 10, 2024
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 2007
Label revision date
October 10, 2024
Manufacturer
Aspen Air U. S. , LLC
Registration number
NDA205863
NDC root
42914-010
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 highly purified form of nitrogen, with an assay of at least 99.998%. It is manufactured in accordance with the FDA’s Current Good Manufacturing Practice regulations and Medical Gas Guidelines, ensuring that it meets strict quality and safety standards. This product is primarily used in various industrial applications and is not approved for human drug use unless delivered to a properly registered user.

The Certificate of Analysis for nitrogen NF confirms that the product has been tested for specific criteria, including the absence of odor and minimal levels of impurities such as oxygen and carbon monoxide. This ensures that the nitrogen is suitable for its intended uses, providing peace of mind regarding its quality and safety.

Uses

This nitrogen NF is specifically designated for use by properly registered users and is not approved for human drug use outside of that context. It's important to understand that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this substance. Always ensure that you are using medications and substances as directed and within the guidelines provided by health authorities.

Dosage and Administration

When using this medication, you will be inhaling it directly into your lungs. This method is known as respiratory (inhalation) administration. The active ingredient in this medication is nitrogen, which is present in a concentration of 99 liters in every 100 liters of the solution.

To use the medication, simply follow the instructions provided for inhalation. Make sure to use it as directed to ensure you receive the correct dosage. If you have any questions about how to properly use this inhalation method, don’t hesitate to ask your healthcare provider for guidance.

What to Avoid

It’s important to know that this nitrogen NF is not approved for human drug use. Therefore, you should not take or use this product unless it is delivered to a properly registered user. There are no specific details regarding controlled substance classification, abuse, misuse, or dependence concerns associated with this product, but the key takeaway is to avoid using it if you do not meet the necessary registration requirements. Always prioritize your safety and consult with a healthcare professional if you have any questions or concerns.

Side Effects

There are no known side effects or adverse reactions associated with nitrogen gas when used as a human prescription drug. The information available does not indicate any warnings or concerns regarding its use. If you have any specific questions or concerns, it's always best to consult with your healthcare provider for personalized advice.

Warnings and Precautions

If you are considering using this nitrogen NF, please be aware that it is not approved for human drug use unless it is delivered to a properly registered user. This means that it should only be used by individuals or entities that have the appropriate authorization.

Currently, there are no specific general precautions or laboratory tests associated with this product mentioned in the information provided. If you have any concerns or questions about its use, it’s always best to consult with a healthcare professional for guidance.

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 extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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, as this will help healthcare professionals provide the best care. Always remember that acting quickly can make a significant difference in the outcome.

Pregnancy Use

It’s important to note that this medication is not approved for human use, which means there is no available information about its safety during pregnancy. This includes a lack of details on how it may affect you or your baby, any necessary dosage adjustments, or specific precautions you should take if you are pregnant or planning to become pregnant.

Given this uncertainty, it’s crucial to consult with your healthcare provider before considering any medication, especially if you are pregnant or may become pregnant. They can provide guidance tailored to your individual health needs and circumstances.

Lactation Use

When considering breastfeeding, it's important to be aware that if a specific nitrogen product is not delivered to a properly registered user, it is not approved for human drug use. This means that using such a product while breastfeeding could pose risks, as it may not have been evaluated for safety in nursing mothers or their infants.

Always consult with your healthcare provider before using any medication or product while breastfeeding to ensure it is safe for you and your baby. Your health and your baby's well-being should always come first.

Pediatric Use

It's important to know that if this nitrogen NF (a type of medical product) is not given to someone who is properly registered to use it, then it is considered "Not approved for human drug use." This means that it should not be used for children or anyone else unless the necessary registration is in place.

As a parent or caregiver, always ensure that any medical product you consider for your child is approved for their use and that it is administered by a qualified professional. This helps ensure their safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding age-related considerations, dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidance on how the medication may affect older patients differently compared to younger individuals.

If you are caring for an older adult, it’s important to consult with a healthcare provider for personalized advice and to discuss any potential risks or necessary adjustments in treatment. Always ensure that any medication is taken under the supervision of a healthcare professional, especially for older individuals who may have unique health needs.

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 and what steps to take for your safety.

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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get the best care possible.

Storage and Handling

Before using the product, ensure that the hose caps (plugs) are securely in place to prevent any leaks during delivery. It's important to check that the gaskets are either suitable for use or new, as this helps maintain safety and effectiveness. Prior to filling the vessel, make sure to purge the hose, which means clearing it of any unwanted substances. After use, always recap (plug) the hose for proper storage.

Please remember that this nitrogen NF product is not approved for human drug use unless it is delivered to a properly registered user. Following these guidelines will help ensure safe handling and storage of the product.

Additional Information

You will use this medication through your respiratory system by inhalation. This method allows the medication to work directly in your lungs. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Nitrogen NF?

Nitrogen NF is a product supplied under a Certificate of Analysis, manufactured in compliance with FDA regulations.

Is Nitrogen NF approved for human drug use?

No, Nitrogen NF is not approved for human drug use unless delivered to a properly registered user.

What are the specifications for Nitrogen NF?

Nitrogen NF must meet specific testing criteria, including an assay of ≥ 99.998% and no odor.

How is Nitrogen NF administered?

Nitrogen NF is administered via inhalation through the respiratory route.

What precautions should be taken during delivery of Nitrogen NF?

Ensure hose caps are in place, gaskets are suitable, the hose is purged before filling, and the hose is recapped for storage.

Are there any teratogenic or nonteratogenic effects associated with Nitrogen NF?

No teratogenic or nonteratogenic effects are mentioned for Nitrogen NF.

What should I do if I receive Nitrogen NF without proper registration?

If Nitrogen NF is not delivered to a properly registered user, it is not approved for human drug use.

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

This document serves as the Certificate of Analysis for nitrogen NF Lot # ______________. The nitrogen NF product is manufactured in accordance with the FDA’s Current Good Manufacturing Practice regulations and the FDA’s Medical Gas Guidelines, as per the procedures established by Aspen Air Medical Gas.

The Certificate of Analysis will include results from product testing, which will be documented below upon delivery to a registered nitrogen NF customer.

Testing parameters include:

  • Assay: Specification ≥ 99.998%; Results: ____.

  • Identification: Specification Nitrogen; Results: ____.

  • Odor: Specification None; Results: ____.

  • Oxygen: Specification ≤ 10 ppm (0.001%); Results: ____.

  • Carbon Monoxide: Specification ≤ 10 ppm (0.001%); Results: ____.

The trace oxygen analyzer utilized is the AIT-21 Model# Teledyne 3000TAEU, and the carbon monoxide analyzer is the AIT-22 Model# Teledyne GFC 7001E. These analyzers have been validated as acceptable alternatives to the official NF method, with the validation study available for review upon request. Odor testing was conducted using the olfactory method.

Uses and Indications

This nitrogen NF is indicated for use only by properly registered users and is not approved for human drug use outside of this context. There are no teratogenic or nonteratogenic effects associated with this product as per the available data.

Dosage and Administration

The active ingredient, Nitrogen 99 L in 100 L, is administered via inhalation through the respiratory route. Healthcare professionals should ensure that the inhalation technique is appropriate for the patient to maximize the therapeutic effect.

It is essential to follow the recommended dosing guidelines specific to the patient's condition and response to treatment. Regular monitoring of the patient's response to therapy is advised to adjust the dosage as necessary.

Contraindications

This nitrogen NF is contraindicated for human drug use. The product is not approved for administration to individuals who are not properly registered users.

Warnings and Precautions

The use of this nitrogen NF is strictly regulated. It is imperative to ensure that the product is delivered only to a properly registered user, as any other use constitutes a violation of its approval status. Specifically, the product is “Not approved for human drug use.”

Healthcare professionals must remain vigilant regarding the distribution and administration of this product to prevent misuse and ensure compliance with regulatory standards. No additional general precautions or laboratory tests have been specified in the provided information.

In the event of any adverse reactions or concerns regarding the use of this product, healthcare providers should follow established protocols for emergency medical assistance and patient management.

Side Effects

There are no reported adverse reactions associated with nitrogen gas as a human prescription drug. The available information primarily consists of product specifications and compliance details, with no mention of side effects, warnings, or adverse reactions. Consequently, no adverse reactions can be documented for this substance based on the current data.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Nitrogen.
Details

Pediatric Use

Pediatric patients should be aware that if this nitrogen NF is not delivered to a properly registered user, the product is considered “Not approved for human drug use.” Therefore, healthcare professionals must ensure that the product is administered in accordance with regulatory guidelines to avoid any potential misuse or safety concerns.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including age considerations, 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 individualized assessment of treatment risks and benefits.

Pregnancy

The safety of this drug during pregnancy has not been established, as it is not approved for human drug use. Consequently, there is no specific information available regarding its use in pregnant patients, including safety concerns, dosage modifications, or any special precautions that should be taken during pregnancy. Healthcare professionals should exercise caution and consider the potential risks when discussing treatment options with women of childbearing potential.

Lactation

Lactating mothers should be aware that if this nitrogen NF is not delivered to a properly registered user, the product is considered “Not approved for human drug use.” There is no available data on the excretion of this product in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks when advising lactating mothers regarding the use of this product.

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 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 details regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise clinical judgment when managing potential cases.

Healthcare providers should be aware that the lack of documented overdosage information does not preclude the possibility of adverse effects resulting from excessive administration. In the event of suspected overdosage, it is recommended that healthcare professionals monitor the patient closely for any unusual symptoms or reactions.

Should an overdosage occur, supportive care is advised. This may include symptomatic treatment and monitoring of vital signs. Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on management strategies tailored to the specific situation.

In summary, while specific overdosage information is not available, healthcare professionals should prioritize patient safety through careful observation and appropriate management in cases of suspected overdosage.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients that the nitrogen NF product is strictly regulated and is not approved for human drug use if it is not delivered to a properly registered user. It is essential for patients to understand the importance of ensuring that the product is received by an authorized individual to comply with safety and regulatory standards. Providers should emphasize the significance of adhering to these guidelines to prevent misuse and ensure the product's intended application.

Storage and Handling

Hose caps (plugs) must be securely in place prior to delivery to ensure the integrity of the product. Gaskets utilized in the process must either be suitable for use or new to maintain optimal conditions. Prior to filling the vessel, it is essential that the hose is purged to eliminate any contaminants. For storage purposes, the hose must be recapped (plugged) to prevent exposure to the environment.

It is important to note that if this nitrogen NF is not delivered to a properly registered user, the product is considered “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 Aspen Air U. S. , LLC. 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 (NDA205863) 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.