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Ibuprofen

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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 2023
Label revision date
February 20, 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
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 2023
Label revision date
February 20, 2025
Manufacturer
Strategic Sourcing Services
Registration number
ANDA210602
NDC roots
70677-1115, 70677-1116, 70677-1117, 70677-1118
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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, available in various flavors such as berry, bubble gum, and grape. It is commonly used to temporarily relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever, making it a versatile option for managing discomfort and illness.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It also helps to reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

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 shake the bottle well before each use. To measure your dose accurately, use only the enclosed dosing cup—other devices may not provide the correct amount.

When it comes to how often you can take this medication, you can repeat the dose every 6 to 8 hours if needed, but do not exceed four doses in a single day. The amount you should take depends on your child's weight. For children under 24 pounds (under 2 years), it's best to consult a doctor first. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL; for 36 to 47 pounds (ages 4-5), it's 7.5 mL; for 48 to 59 pounds (ages 6-8), it's 10 mL; for 60 to 71 pounds (ages 9-10), it's 12.5 mL; and for children weighing 72 to 95 pounds (11 years), the dose is 15 mL. 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, so it's important to be aware of them. You should watch for signs of a severe allergic reaction, especially if you or your child is allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If any of these occur, stop using the medication and seek medical help immediately.

There are also risks of stomach bleeding, heart attack, and stroke associated with ibuprofen, particularly if used improperly or for extended periods. Be cautious if your child has a history of stomach ulcers, is taking blood thinners, or has other health issues. If your child experiences symptoms like faintness, vomiting blood, chest pain, or weakness, contact a doctor right away. Additionally, if fever or pain worsens or lasts more than three days, or if new symptoms appear, seek medical advice. Always consult a doctor before use if your child has any serious health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin issues, stop using it immediately and seek medical help. Additionally, be aware that ibuprofen can 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child has a severe sore throat, especially with a high fever or other concerning symptoms, consult a doctor right away. You should seek emergency medical assistance in case of an overdose or if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within a few days. Always monitor for any new symptoms and consult your doctor if you have concerns.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy can pose risks to your baby, including potential heart and kidney issues.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of pregnancy. They may suggest dosage adjustments based on your specific situation and the stage of your pregnancy. Your health and your baby's health are the top priority, so it's best to seek professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to be cautious when using this medication for children. You should avoid giving it to children under 3 years old unless a doctor specifically advises you to do so. For children under 24 pounds (less than 2 years), it's essential to consult a doctor for the correct dosage.

Here’s a quick guide for dosing based on your child's weight: for those weighing 24-35 pounds (ages 2-3), give 5 mL; for 36-47 pounds (ages 4-5), give 7.5 mL; for 48-59 pounds (ages 6-8), give 10 mL; for 60-71 pounds (ages 9-10), give 12.5 mL; and for 72-95 pounds (age 11), give 15 mL. Remember, do not exceed 4 doses in a 24-hour period. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop use immediately and seek medical advice. If your child does not feel better within 24 hours, it's also important to consult a doctor.

Geriatric Use

As an older adult or caregiver, it's important to know that there are no specific dosage adjustments or safety concerns noted for elderly patients regarding this medication. This means that the standard dosage can generally be used without special modifications for older individuals. However, always consult with a healthcare provider to ensure that this medication is appropriate for your specific health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware that ibuprofen can lead to serious side effects, especially when combined with certain medications. For instance, taking ibuprofen alongside blood thinners (medications that help prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding. Additionally, if you are using other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding is even higher.

If you or your child are on diuretics (medications that help remove excess fluid from the body), it's crucial to consult your healthcare provider before using ibuprofen. Furthermore, using NSAIDs, except for aspirin, can elevate the risk of heart attack, heart failure, and stroke, particularly if taken in higher doses or for extended periods. Always discuss your medications and any lab tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality. Before using, check that the carton is unopened and that the printed bottle neckband is intact; do not use the product if either of these conditions is not met, as this could compromise safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication with food or milk if you experience stomach upset. The recommended dosing is every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen used for?

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

What flavors does ibuprofen come in?

Ibuprofen is available in various flavors, including berry, original berry, bubble gum, and grape.

What should I do if my child has an allergic reaction to ibuprofen?

If your child experiences symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop use and seek medical help immediately.

How should ibuprofen be administered?

Shake well before using and use only the enclosed dosing cup. Do not exceed 4 doses in a 24-hour period.

What are the dosing recommendations for ibuprofen?

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

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe stomach bleeding, especially if taken with certain medications or if the child has a history of stomach problems. It also increases the risk of heart attack and stroke.

Can ibuprofen be used during pregnancy?

Ibuprofen is contraindicated during pregnancy, particularly in the third trimester, due to potential risks to the fetus.

What should I do if my child does not get relief from ibuprofen?

If your child does not experience relief within the first 24 hours of treatment, or if symptoms worsen, consult a doctor.

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 bottle neckband is broken or missing.

Packaging Info

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

Packaging configurations for Ibuprofen Oral.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen oral suspension is available in various flavors and container sizes. The formulations include a berry flavor in a 118 mL carton, an original berry flavor in a 118 mL carton, a bubble gum flavor in a 118 mL carton, a grape flavor in a 118 mL carton, and an original flavor in a 237 mL carton. Each formulation is designed for oral administration and is intended to provide effective relief from pain and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing 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 specific dosing instructions must be followed. Prior to administration, the product should be shaken well to ensure proper mixing. It is imperative to use only the enclosed dosing cup for measurement; no other dosing devices should be utilized to avoid inaccuracies.

The recommended dosing is as follows:

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

  • 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.

Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. It is essential to adhere strictly to these guidelines and not exceed the recommended dosage. For any uncertainties or specific patient considerations, healthcare professionals should consult with a physician.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, and it should not be administered to children under three years of age unless specifically directed by a physician.

In the event of an overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical attention if the child exhibits any of the following signs of 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 redness or swelling occurs in the affected area, or if any new symptoms arise, it is essential to consult a healthcare professional.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of ibuprofen is associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

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

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.

Patients are advised to stop using ibuprofen and seek medical attention if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

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 seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, patients should consult a doctor 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 dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics.

Patients under a doctor's care for any serious condition or those taking other medications should also seek guidance from a healthcare provider or pharmacist prior to using ibuprofen.

Drug Interactions

Ibuprofen has several notable drug interactions that warrant careful consideration.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider alternative pain management strategies if these medications are used together.

Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of gastrointestinal bleeding is further heightened when ibuprofen is taken alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. Patients should be counseled to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

Diuretics Ibuprofen may interact with diuretics, potentially affecting their efficacy. It is recommended that healthcare providers consult with a physician if a patient, particularly a child, is concurrently taking a diuretic to ensure appropriate management and monitoring.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when these medications are used beyond the recommended duration or dosage. Patients should be advised to adhere strictly to dosing guidelines and to discuss any concerns regarding long-term use with their healthcare provider.

Packaging & NDC

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

Packaging configurations for Ibuprofen Oral.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children weighing less than 24 lbs (under 2 years), dosing instructions must be obtained from a doctor.

The recommended dosages for pediatric patients based on weight are as follows: for those weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL. It is important not to exceed 4 doses within a 24-hour period.

Healthcare professionals should exercise caution and consult a doctor if the child has a history of stomach problems, is dehydrated, or has other serious health conditions. Parents or caregivers should be advised to stop use and seek medical attention if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. If the child does not experience relief within the first 24 hours of treatment, a consultation with a healthcare provider is recommended.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, which can include potential cardiovascular and renal complications.

Dosage adjustments may be necessary based on the stage of pregnancy and individual patient factors. It is essential for pregnant women to consult a healthcare provider prior to using ibuprofen, especially if they are in the later stages of pregnancy, to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. Additionally, there is no information available about the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

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

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Additionally, there is no information available pertaining to 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, as well as in those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used at higher doses or for extended durations beyond the recommended guidelines.

Patient Counseling

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

Additionally, healthcare providers should inform patients that if they experience stomach upset, the medication can be taken with food or milk to help alleviate this side effect.

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 packaging prior to use; the product should not be utilized if the carton is opened or if the printed bottle neckband 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

Patients should take the medication with food or milk if they experience stomach upset. The recommended dosing frequency is every 6 to 8 hours, with a maximum of four doses per day. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

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