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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2009
Label revision date
June 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
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 2009
Label revision date
June 11, 2025
Manufacturer
Marc Glassman, Inc.
Registration number
ANDA079174
NDC root
68998-110
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 available in 200 mg tablet form that serves as a pain reliever and fever reducer. It is commonly used to temporarily relieve minor aches and pains associated with headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. Additionally, ibuprofen can help 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 various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to go about your day with less pain and discomfort.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 caplet every 4 to 6 hours as long as you have symptoms. If you find that 1 caplet isn’t enough to relieve your pain or fever, you can take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises you to do so.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, do not take it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for individuals over 60, those with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or slurred speech. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications, especially aspirin for heart conditions.

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 immediately and seek medical help. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use it for longer than recommended. It can also increase the risk of heart attack, heart failure, and stroke, especially if misused.

Before using ibuprofen, consult your doctor if you have had allergic reactions to pain relievers, have stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics or aspirin for heart conditions. 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 or stroke, stop taking ibuprofen and contact your doctor. In case of an overdose, seek immediate medical assistance or call Poison Control at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s essential to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can give them 1 caplet every 4 to 6 hours as needed for symptoms. If one caplet doesn’t relieve pain or fever, you may give them 2 caplets. However, make sure not to exceed 6 caplets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and follow these guidelines to ensure your child's well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medication use. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. Additionally, using more than the recommended dose or taking medication for longer than advised can increase your risk of heart attack, heart failure, and stroke.

Before starting any new medication, it's wise to consult with your doctor, especially if you have conditions like high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, asthma, or a history of stroke. Taking these precautions can help ensure your safety and well-being.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, including over-the-counter options like ibuprofen. For instance, if you are using aspirin to prevent heart attacks or strokes, taking ibuprofen may reduce its effectiveness. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Moreover, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can raise your chances of experiencing serious heart issues, such as heart attack or stroke, especially if you take them more often or for longer than recommended. Always consult with your healthcare provider to ensure your medications are safe and effective for your health needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, as temperatures above 40°C (104°F) can damage the product.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is Ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and older?

You should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may take 2 caplets, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

What should I do if I experience signs of stomach bleeding?

Stop using Ibuprofen and call your doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Are there any warnings associated with taking Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke, especially if used more than directed or for longer than directed.

Can I use Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Ibuprofen. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have a history of stomach problems?

You should ask a doctor before using Ibuprofen if you have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to you.

What are the storage conditions for Ibuprofen?

Store Ibuprofen at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

What should I do if I have an allergic reaction to Ibuprofen?

If you experience an allergic reaction, stop using Ibuprofen and seek medical help immediately.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) available in tablet form, specifically as 200 mg coated caplets. These capsule-shaped tablets are indicated for the relief of pain and reduction of fever. Each bottle contains 100 coated caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

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 of such reactions can 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe gastrointestinal bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use the medication in excess of the recommended guidelines.

Patients should refrain from using ibuprofen if they have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer. It is also contraindicated for use immediately before or after cardiac surgery. Prior to administration, healthcare professionals should advise patients to consult a physician if they have experienced adverse effects from pain relievers or fever reducers, if the warning regarding stomach bleeding is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additional caution is warranted for patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as well as those taking diuretics.

Healthcare professionals should also recommend that patients consult a doctor or pharmacist before using ibuprofen if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the efficacy of aspirin in this context. Furthermore, patients under medical supervision for serious conditions or those taking other medications should seek professional advice prior to use.

In the event of an allergic reaction, it is crucial to stop using ibuprofen and seek immediate medical attention. In cases of overdose, medical help should be sought or the Poison Control Center contacted at 1-800-222-1222.

Patients should discontinue use and contact a healthcare provider if they experience any signs of gastrointestinal 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 consultation. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

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. Additionally, the use of this NSAID carries a warning for the potential risk of severe stomach bleeding, especially in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

The risk of cardiovascular events, including heart attack, heart failure, and stroke, is also heightened with the use of NSAIDs, excluding aspirin. These events can be fatal, particularly when the medication is used in excess or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Prior to using this product, patients should consult a healthcare provider if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek guidance if taking a diuretic or if under a physician's care for any serious condition. Additionally, patients taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids is associated with an increased risk of gastrointestinal bleeding. Clinicians should exercise caution when prescribing ibuprofen to patients on these medications and consider monitoring for signs of gastrointestinal complications.

Cardiovascular Risks The use of NSAIDs, including ibuprofen, is linked to an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy and consider alternative pain management strategies, especially in patients with pre-existing cardiovascular conditions. Regular monitoring of cardiovascular status may be warranted in patients receiving long-term NSAID therapy.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may experience an increased risk of severe stomach bleeding when using this medication. Therefore, careful consideration and monitoring are advised when prescribing to this population.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is heightened in geriatric patients who exceed the recommended dosage or duration of use. It is crucial for healthcare providers to evaluate the appropriateness of treatment regimens in elderly patients, ensuring adherence to prescribed dosages.

Before initiating therapy, healthcare providers should inquire about the presence of comorbid conditions in elderly patients, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These factors may necessitate further assessment and potential dose adjustments to mitigate risks associated with the medication. Regular monitoring and patient education on the signs of adverse effects are essential components of care for geriatric patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Side effects may occur, and individuals are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

In cases of potential stomach bleeding, individuals should discontinue use and consult a healthcare professional if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

Additionally, if symptoms indicative of heart problems or stroke arise, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, it is advised to stop use and seek medical attention.

Patients should also consult a doctor if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms develop.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to take the medication with food or milk if they experience stomach upset. It is important for patients to consult with their healthcare provider before using this medication if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them. Additionally, patients with a history of stomach issues, such as heartburn, or those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use.

Patients taking a diuretic should be encouraged to discuss their medication regimen with their healthcare provider. Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in this context. It is also recommended that patients under a doctor's care for any serious condition or those taking any other medications discuss their situation with their healthcare provider prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for 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 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.

Learn more in our Editorial Policy

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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.