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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 24, 2025
Manufacturer
Discount Drug Mart, Inc
Registration number
ANDA210149
NDC root
53943-682
Drug Information (PDF)
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

Ibuprofen is a medication that comes in an oral suspension form, specifically designed for children. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever and provides relief that can last up to 8 hours.

This formulation is dye-free, contains no artificial sweeteners, and is alcohol-free, making it a gentle option for young patients. It has a pleasant mixed berry flavor, which can make it easier for children to take.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before use.

To find the right dose for your child, refer to the dosing chart provided. If possible, use your child's weight to determine the dosage; if not, you can use their age. Make sure to use only the enclosed dosing cup for measuring the dose, as other devices may not provide accurate measurements. For example, if your child weighs between 24 and 35 pounds and is aged 2 to 3 years, the correct dose is 5 mL. Always consult a doctor if your child weighs less than 24 pounds or if you have any questions about the appropriate dosage.

What to Avoid

It's important to ensure your child’s safety when considering medication. You should not use this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using it right before or after your child has heart surgery, as this can pose serious risks.

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where the body becomes reliant on a substance) can also occur, so it's crucial to follow these guidelines closely to protect your child's health.

Side Effects

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. Symptoms to watch for include hives, wheezing (asthma), skin redness, facial swelling, shock, rash, and blisters. Additionally, this medication may lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

If your child experiences symptoms like faintness, vomiting blood, black or bloody stools, or persistent stomach pain, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. Always monitor for worsening symptoms or new issues, and do not use ibuprofen for more than three days without medical advice.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, wheezing, skin reddening, facial swelling, or blisters, stop using the medication and seek medical help immediately. Additionally, ibuprofen may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

It's important to monitor your child closely. If they experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, contact your doctor right away. You should also reach out to a healthcare professional if your child shows symptoms of heart problems or stroke, does not find relief within 24 hours, or if fever or pain worsens or lasts more than three days. For any new symptoms or if redness or swelling appears in the painful area, consult your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical attention immediately.

Signs of an overdose can vary, but if you notice any severe or concerning symptoms, do not hesitate to contact a healthcare professional or call emergency services. It's always better to be safe and get checked out if you have any doubts about your health after taking medication.

Pregnancy Use

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach the use of any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy. Your healthcare provider can offer personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor first. For those weighing 24-35 pounds (ages 2-3), the recommended dose is 5 mL, while children weighing 36-47 pounds (ages 4-5) should receive 7.5 mL. Always follow the dosing chart carefully and never exceed the recommended amount.

If your child has certain health issues—like a history of stomach problems, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver or kidney disease, or asthma—it's crucial to consult a doctor before use. Additionally, if your child shows any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop the medication immediately and seek medical advice. If there’s no improvement within the first 24 hours, or if fever or pain worsens or lasts more than 3 days, please consult a doctor.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice. They can help determine if this medication is appropriate for you or your loved one, considering any unique health needs or potential risks.

Always discuss any existing health conditions or medications with your doctor, as older adults may have different responses to treatments. Your healthcare provider can guide you on the best practices for safe and effective use.

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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help you understand how your kidney health may affect your treatment.

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 be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the inner seal, marked "SEALED for YOUR PROTECTION," is intact. If either of these conditions is not met, do not use the product, as it may not be safe. Always handle the product with care to ensure your safety and the best results.

Additional Information

You should take this medication orally. If you ever suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Ibuprofen?

Ibuprofen is an oral suspension, USP (NSAID), available in a concentration of 100 mg per 5 mL.

What does Ibuprofen treat?

Ibuprofen relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

How long does the effect of Ibuprofen last?

The effects of Ibuprofen can last up to 8 hours.

What should I do before giving Ibuprofen to my child?

Always consult a doctor if your child has a history of stomach problems, is not drinking fluids, or has lost a lot of fluid due to vomiting or diarrhea.

What is the dosing chart for Ibuprofen?

The dosing chart varies by weight and age. For example, a child weighing 24-35 lbs (2-3 years) should receive 5 mL.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions and stomach bleeding, especially if the child has had stomach ulcers or is taking other NSAIDs.

What should I do if my child experiences signs of stomach bleeding?

If your child feels faint, vomits blood, or has bloody or black stools, stop use and consult a doctor immediately.

Can I use Ibuprofen if my child has had an allergic reaction to pain relievers?

No, do not use Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is there any information about using Ibuprofen during pregnancy?

The provided text does not mention any specific statements regarding the use of Ibuprofen during pregnancy.

How should Ibuprofen be stored?

Store Ibuprofen between 20-25°C (68-77°F) and do not use if the carton is opened or the inner seal is broken.

Packaging Info

Below are the non-prescription pack sizes of Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Ibuprofen Oral Suspension, USP is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever in children. Each 5 mL dose contains 100 mg of ibuprofen. The formulation is dye-free, alcohol-free, and contains no artificial sweeteners, with a mixed berry flavor for palatability. The product is available in a 4 FL OZ (120 mL) bottle. It is designed to provide relief that lasts up to 8 hours. The National Drug Code (NDC) for this product is 53943-682-03.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to adhere strictly to the recommended dosages and not exceed the directed amount.

Prior to administration, the product must be shaken well to ensure proper mixing. The enclosed dosing cup should be utilized for measuring the dose; no other dosing devices should be employed to avoid inaccuracies.

The following dosing chart provides guidance for administration:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For patients weighing between 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing between 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing between 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing between 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing between 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response.

Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure safe use in patients, particularly children.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Gastrointestinal Risks As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, and individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen). It is crucial to adhere to the recommended dosage and duration of treatment to minimize this risk.

Cardiovascular Concerns The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended duration.

Sore Throat Warning Healthcare providers should be vigilant for patients presenting with severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Ibuprofen should not be used for more than two days in such cases, nor should it be administered to children under three years of age unless directed by a physician.

Monitoring and Emergency Response Healthcare professionals should advise caregivers to discontinue ibuprofen and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, further evaluation is necessary. Redness or swelling in the affected area, as well as the emergence of any new symptoms, should also prompt a consultation with a healthcare provider.

In cases of suspected overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage may increase the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include gastrointestinal symptoms, and patients should be advised to discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Other symptoms warranting medical attention include persistent stomach pain, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should seek medical advice if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, or if any new symptoms arise.

Before using this product, it is recommended that patients consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics.

In pediatric patients, it is particularly important to avoid use in children under three years of age without medical guidance, especially in cases of severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is particularly pronounced in pediatric patients who may also be taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, or naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen in conjunction with these medications. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply:

  • For children under 24 lbs (under 2 years), consult a doctor.

  • For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

  • For those weighing 48-59 lbs (6-8 years), the dose is 10 mL.

  • For children weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

  • For those weighing 72-95 lbs (11 years), the dose is 15 mL.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

It is crucial not to exceed the recommended dosage. If a child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, parents should discontinue use and seek medical advice. Additionally, if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, as elderly patients often have altered pharmacokinetics and may be more susceptible to medication-related complications.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

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 information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions

In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms

While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to provide supportive care tailored to the patient's needs, which may include intravenous fluids, monitoring of electrolytes, and other interventions as clinically indicated.

In summary, due to the absence of specific overdosage information, a cautious and supportive approach is recommended for the management of any suspected cases.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use. Symptoms indicative of heart problems or stroke reported include chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the carton prior to use; the product should not be utilized if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients that in the event of an overdose, immediate medical assistance should be sought, or they should contact a Poison Control Center at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (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 Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory 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.

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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.