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Childrens Ibuprofen Oral Suspension

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 23, 2024
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
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 2020
Label revision date
December 23, 2024
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
ANDA210602
NDC root
63868-796
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It is a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen is effective in reducing fever and provides relief that can last up to 8 hours.

This medication comes in a bubble gum flavor and is alcohol-free, making it more appealing for children. It contains 100 mg of ibuprofen per 5 mL and is comparable to the active ingredient found in Children's Motrin®.

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 are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; using any other device could lead to incorrect dosing. Depending on your child's weight, the amount you should give varies. For children under 24 pounds (younger than 2 years), it's best to consult a doctor first. If your child weighs between 24 and 35 pounds (ages 2-3), you should give them 5 mL. For those weighing 36 to 47 pounds (ages 4-5), the dose is 7.5 mL, and for children weighing 48 to 59 pounds (ages 6-8), the dose increases to 10 mL. If your child is between 60 and 71 pounds (ages 9-10), the dose is 12.5 mL, and for those who weigh 72 to 95 pounds (11 years old), you should give 15 mL.

If needed, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. Always follow your doctor's instructions if they provide specific guidance.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to Ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you notice any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers or bleeding issues, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. There is also an increased risk of heart attack and stroke with NSAID use, especially if taken in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or chest pain, or if their condition does not improve within 24 hours, contact a doctor right away.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a doctor. Always be alert for any new symptoms or signs of redness and swelling in the painful area.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

It's important to act quickly. If an overdose occurs, seek immediate medical attention or contact a Poison Control Center for guidance. Your health and safety are the top priority, so don’t hesitate to get help.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of ibuprofen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

When considering medication for your child aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight. For children under 3 years old, you should consult a doctor before use. Here’s a quick reference for dosing: if your child weighs under 24 lbs, ask a doctor; for 24-35 lbs (ages 2-3), give 5 mL; for 36-47 lbs (ages 4-5), give 7.5 mL; for 48-59 lbs (ages 6-8), give 10 mL; for 60-71 lbs (ages 9-10), give 12.5 mL; and for 72-95 lbs (age 11), give 15 mL.

Always use the enclosed dosing cup to measure the medication and never exceed the recommended dose. If your child has a history of stomach issues, is under treatment for a serious condition, or is taking other medications, consult your doctor before administering this medication. If necessary, you can repeat the dose every 6-8 hours, but do not give more than four doses in a day.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the manufacturer has not identified any unique safety concerns or special precautions for elderly patients.

As always, it’s important to discuss your individual health needs with your healthcare provider, especially if you are an older adult or caring for one. They can help determine the best approach for you, considering any other medications you may be taking or health conditions you may have.

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 treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For example, 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. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can further heighten this risk.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand potential interactions 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 20-25ºC (68-77ºF). This helps maintain its quality and performance.

When handling the product, be cautious not to use it if the carton is opened or if the printed neckband on the bottle is broken or missing, as this could indicate that the product is no longer safe to use. Always check these details before proceeding.

Additional Information

No further information is available.

FAQ

What is ibuprofen used for?

Ibuprofen is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for children?

The dosage varies by weight: for children 2-3 years (24-35 lbs), it's 5 mL; for 4-5 years (36-47 lbs), it's 7.5 mL; for 6-8 years (48-59 lbs), it's 10 mL; for 9-10 years (60-71 lbs), it's 12.5 mL; and for 11 years (72-95 lbs), it's 15 mL.

How often can ibuprofen be given?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and seek medical help immediately.

Can ibuprofen be used during pregnancy?

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy, but it is always best to consult a doctor.

Is ibuprofen safe for nursing mothers?

Nursing mothers should consult a doctor before using ibuprofen, as it may be excreted in breast milk and its effects on nursing infants are not well studied.

What flavor does ibuprofen come in?

Ibuprofen is available in a bubble gum flavor and is alcohol-free.

How should ibuprofen be stored?

Store ibuprofen between 20-25ºC (68-77ºF) and do not use if the carton is opened or the bottle neckband is broken or missing.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's ibuprofen is an oral suspension formulation classified as a nonsteroidal anti-inflammatory drug (NSAID), indicated for use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of the active ingredient, providing effective pain relief and fever reduction. The suspension is designed to last up to 8 hours, ensuring prolonged therapeutic effects. It is alcohol-free and features a bubble gum flavor to enhance palatability. The product is available in a 4 fl oz (118 mL) volume, with the National Drug Code (NDC) 63868-796-04.

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

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; the use of any other dosing device is not recommended.

Dosing is determined by the patient's weight, as outlined in the following chart:

  • For patients weighing under 24 lbs (under 2 years), consultation with a physician is advised.

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

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

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

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

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

If necessary, doses may be repeated every 6 to 8 hours; however, it is important not to exceed a total of 4 doses in a 24-hour period. Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that 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 is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days in such instances, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

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, or if there is noticeable redness or swelling in the affected area, medical consultation is necessary. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. In the event of an allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

The use of ibuprofen is also associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those using other NSAIDs concurrently. The risk of stomach bleeding increases with prolonged use or higher doses than recommended.

Additionally, ibuprofen carries warnings regarding an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for extended periods.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should consult a healthcare provider promptly.

Common adverse reactions may include gastrointestinal symptoms, and patients should be advised to stop use and seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Furthermore, patients should seek medical advice if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. Redness or swelling in the affected area or the emergence of any new symptoms should also prompt a medical evaluation.

Drug Interactions

Ibuprofen has been identified to interact with certain classes of medications, particularly anticoagulants and corticosteroids. When administered concurrently with blood-thinning agents, there is an increased risk of gastrointestinal bleeding. This risk is further amplified in pediatric patients who are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside 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 reported in the available data.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. For children weighing under 24 lbs, use is not recommended unless directed by a doctor. For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lbs (ages 4-5 years), 7.5 mL; for 48-59 lbs (ages 6-8 years), 10 mL; for 60-71 lbs (ages 9-10 years), 12.5 mL; and for 72-95 lbs (age 11 years), 15 mL.

It is crucial to consult a doctor if the child has a history of stomach problems, is under medical care for any serious condition, or is taking other medications. The medication should not be administered to children under 3 years of age unless specifically directed by a healthcare professional.

Dosing should not exceed the recommended amounts, and the enclosed dosing cup must be used; other dosing devices are not appropriate. If necessary, doses may be repeated every 6-8 hours, but the total daily dosage should not exceed four doses.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

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 text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 in the available information.

Overdosage

Overdosage of ibuprofen may lead to severe symptoms that require prompt medical intervention. Healthcare professionals should be aware of the potential manifestations of an overdose, which can include nausea, vomiting, stomach pain, drowsiness, and headache.

In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Timely intervention is essential to mitigate the risks associated with ibuprofen overdosage and to ensure appropriate treatment measures are implemented.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Similarly, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any additional insights. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, those taking blood thinners or steroids, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting, may indicate serious underlying conditions.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be informed to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for healthcare providers to recommend consulting a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Patients should also be encouraged to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, healthcare providers should advise patients to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Finally, patients should be reminded to discuss with their doctor or pharmacist if the child is taking a diuretic or is under medical care for any serious condition, as well as to inform them of any other medications the child is currently taking.

Storage and Handling

The product is supplied in a secure carton, and it is essential to ensure that the carton remains unopened and that the printed bottle neckband is intact.

Storage conditions require that the product be maintained at a temperature range of 20-25ºC (68-77ºF). Proper handling is crucial to preserve the integrity of the product; therefore, it should not be used if the carton has been opened or if the printed bottle neckband is broken or missing.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, 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 Oral Suspension, 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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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.