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Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
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 2025
Label revision date
April 7, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
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 2025
Label revision date
April 7, 2023
Manufacturer
Strides Pharma Inc
Registration number
ANDA214071
NDC roots
59556-118, 59556-233
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Ibuprofen Concentrated Drops are a type of oral suspension that contains 50 mg of ibuprofen (a nonsteroidal anti-inflammatory drug, or NSAID) per 1.25 mL. This medication is designed to help relieve minor aches and pains, such as those caused by the common cold, flu, headaches, and toothaches. It also works to reduce fever, providing relief for children aged 6 to 23 months.

These drops are available in two flavors—White Mix Berry and Grape—and are formulated to be dye-free and alcohol-free. The effects of ibuprofen can last for up to 8 hours, making it a convenient option for managing discomfort and fever in young children.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions like the cold, flu, headaches, and toothaches.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

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

To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age. For children under 6 months, it's best to consult a doctor before administering. For children weighing between 12-17 pounds (6-11 months old), the dose is 1.25 mL, and for those weighing 18-23 pounds (12-23 months old), the dose is 1.875 mL. You can repeat the dose every 6 to 8 hours if needed, but do not use it more than four times a day. Always measure the dose with the dosing device included in the package, and avoid using any other measuring device to ensure accuracy.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that ibuprofen can cause serious allergic reactions, particularly if you are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID), can lead to severe stomach bleeding, especially if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs.

There are also risks associated with heart attack and stroke when using NSAIDs like ibuprofen, particularly if taken in higher doses or for extended periods. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems or stroke, such as chest pain or weakness on one side of the body, you should stop using ibuprofen and consult a doctor immediately. It's also important to seek medical advice if your symptoms do not improve within 24 hours or if they worsen.

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 skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs. The risk of heart attack, heart failure, and stroke also increases with NSAID use, especially if taken in higher doses or for longer than recommended.

Before giving ibuprofen to your child, consult a doctor if they have had any allergic reactions to pain relievers, are recovering from heart surgery, or have conditions like high blood pressure, kidney disease, or asthma. It's also important to check with a healthcare professional if your child is taking other medications or has been dehydrated due to vomiting or diarrhea.

If you suspect an overdose, contact a Poison Control Center or seek medical help right away. You should also stop using ibuprofen and call your doctor if your child experiences signs of stomach bleeding (like faintness or vomiting blood), symptoms of heart problems or stroke (such as chest pain or weakness), or if their fever or pain worsens or lasts more than three days.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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 ibuprofen while pregnant can pose risks to your developing baby, including potential heart and kidney issues.

Before taking any medication, including ibuprofen, you should consult your healthcare provider. They may suggest dosage adjustments or alternative treatments to ensure your safety and that of your baby. Always prioritize professional guidance when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding and considering using Ibuprofen suspension, it's important to note that there is no specific information available about its effects on nursing mothers or lactation (the process of producing milk). This means that the safety and potential impact on your milk production or your baby are not clearly established.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

It's important to be cautious when giving ibuprofen to children. You should not give it to children under 6 months of age without first consulting a doctor. For children aged 6 to 11 months who weigh between 12 and 17 pounds, the recommended dose is 1.25 mL. If your child is between 12 and 23 months and weighs 18 to 23 pounds, the recommended dose increases to 1.875 mL. This medication is specifically indicated for children aged 6 to 23 months.

Before using ibuprofen, consult a doctor if your child has any history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has had a stroke. It's also important to check with a doctor if your child has not been drinking fluids or has lost a lot of fluid due to vomiting or diarrhea. If your child is on a diuretic (a medication that helps remove excess fluid) or is being treated for a serious condition, seek medical advice first. If you notice any signs of stomach bleeding, symptoms of heart problems or stroke, or if your child's fever or pain worsens or lasts more than three days, stop using the medication and consult a doctor immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have other health issues such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Your doctor can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This ensures that the medication is safe and effective for you.

Additionally, if you have other health conditions like high blood pressure, heart disease, kidney disease, or asthma, make sure to discuss these with your doctor. They will consider all your health issues when determining the best treatment plan for you. Always follow your healthcare provider's guidance to manage your health safely.

Drug Interactions

It's important to be cautious when giving ibuprofen to your child, especially if they are also taking other medications. Ibuprofen can increase the risk of severe stomach bleeding, particularly if your child is on blood thinners (medications that help prevent blood clots) or steroids. Additionally, if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, the risk of stomach bleeding can be even higher.

Before giving ibuprofen, make sure to discuss all medications your child is taking with a healthcare provider or pharmacist. This will help ensure their safety and avoid any potentially serious interactions. Always prioritize open communication about your child's health and medications.

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 check the bottom of the box for the lot number and expiration date, as this information is crucial for confirming the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication every 6 to 8 hours as needed, but do not exceed four doses in a day. If your child experiences stomach upset, it's best to take the medication with food or milk.

Be alert for serious side effects. If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop using the medication and consult a doctor. Additionally, seek medical attention if your child has symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If there is no relief within the first 24 hours, or if fever or pain worsens or lasts more than three days, or if redness or swelling occurs in the painful area, contact a healthcare professional. Always report any new symptoms that arise.

FAQ

What is Ibuprofen Concentrated Drops used for?

Ibuprofen Concentrated Drops are used to reduce fever and relieve minor aches and pains due to the common cold, flu, headaches, and toothaches.

What age group can use Ibuprofen Concentrated Drops?

This product is indicated for use in children aged 6 to 23 months.

How should I dose Ibuprofen Concentrated Drops?

For children aged 6-11 months (12-17 lb), the dose is 1.25 mL. For children aged 12-23 months (18-23 lb), the dose is 1.875 mL. Always consult the dosing chart and do not exceed 4 doses in a day.

What precautions should I take before using Ibuprofen Concentrated Drops?

Consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has had a stroke.

What are the potential side effects of Ibuprofen Concentrated Drops?

Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Seek medical help if the child experiences symptoms like faintness, vomiting blood, or chest pain.

Can I use Ibuprofen Concentrated Drops during pregnancy?

Ibuprofen is contraindicated during pregnancy, especially in the third trimester, as it may pose risks to the developing fetus.

What should I do if I suspect an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

How should I store Ibuprofen Concentrated Drops?

Store the product at 20-25°C (68-77°F) and check the box for the lot number and expiration date.

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 Concentrated Drops are formulated as an oral suspension containing 50 mg of ibuprofen per 1.25 mL. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer, providing relief that lasts up to 8 hours. The product is available in a dye-free and alcohol-free formulation, with a white mix berry flavor for palatability. It is specifically indicated for use in children aged 6 to 23 months. The product is offered in two sizes: 1/2 FL OZ (15 mL) and 1/2 FL OZ (30 mL), with an additional grape-flavored option.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, headaches, and toothaches.

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

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. Dosing should be determined using the provided dosing chart, with weight being the preferred method for dosage calculation; if weight is not available, age may be used as an alternative.

For infants under 6 months of age, it is advised to consult a physician before administration. For infants weighing between 12 to 17 pounds (6 to 11 months of age), the recommended dose is 1.25 mL. For those weighing between 18 to 23 pounds (12 to 23 months of age), the recommended dose is 1.875 mL.

Doses may be repeated every 6 to 8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is imperative to measure the dose using the dosing device provided with the product; the use of any other measuring device is not recommended. Healthcare professionals should ensure that patients do not exceed the directed dosage.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 the risk of causing severe stomach bleeding. This risk 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. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is amplified with prolonged or excessive use.

General precautions should be observed prior to administering ibuprofen. It is contraindicated in children with a history of allergic reactions to any pain reliever or fever reducer. Use is also discouraged immediately before or after heart surgery. Healthcare professionals should be consulted if any of the following conditions apply: the child has a history of stomach bleeding, has experienced adverse effects from pain relievers or fever reducers, has a history of gastrointestinal issues such as heartburn, or has pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, caution is warranted if the child has not been adequately hydrated or has experienced significant fluid loss due to vomiting or diarrhea, or is taking a diuretic. Consultation with a doctor or pharmacist is also advised if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including 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, medical advice should be sought. Any new symptoms that arise should also prompt a consultation with a healthcare provider.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

Severe allergic reactions may occur, 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen. Additionally, the risk of gastrointestinal bleeding increases with prolonged use or higher than recommended dosages.

Patients should also be informed of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the recommended duration or dosage.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include 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, weakness on one side of the body, slurred speech, or leg swelling, warrant immediate medical attention. Furthermore, 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, or if redness or swelling occurs in the affected area, they should seek medical advice. Any new symptoms that arise should also prompt a consultation with a healthcare provider.

Drug Interactions

Ibuprofen has been associated with an increased risk of severe gastrointestinal bleeding, particularly in pediatric patients who are concurrently using anticoagulants or steroid medications. The potential for this adverse effect is further heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

It is imperative that healthcare providers advise caregivers to consult with a physician or pharmacist prior to administering ibuprofen if the child is currently on any other medications. This precaution is essential to ensure safe use and to mitigate the risk of serious complications related to drug interactions. Monitoring for signs of gastrointestinal distress is also recommended in patients receiving ibuprofen in conjunction with these medications.

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 6 months of age should not be given ibuprofen without prior consultation with a healthcare professional. The product is indicated for use in children aged 6-23 months, with specific dosing recommendations based on weight. For children aged 6-11 months weighing between 12-17 pounds, the recommended dose is 1.25 mL. For those aged 12-23 months weighing between 18-23 pounds, the recommended dose is 1.875 mL.

Healthcare professionals should advise parents or caregivers to consult a doctor if the child has a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has experienced a stroke. Additionally, consultation is necessary if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if the child is taking a diuretic or is under medical care for any serious condition.

Parents or caregivers should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the painful area, or presents any new symptoms.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. The administration of ibuprofen may pose risks to the developing fetus, including potential cardiovascular and renal complications. Due to these risks, pregnant patients should avoid using ibuprofen unless specifically directed by a healthcare professional.

Dosage adjustments may be necessary, and it is advised that women of childbearing potential consult a healthcare provider before using ibuprofen during pregnancy to ensure safety for both the mother and the fetus.

Lactation

There is no specific information regarding the use of Ibuprofen suspension in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as kidney disease. It is essential to assess the patient's overall health status, including any history of high blood pressure, heart disease, liver cirrhosis, asthma, or previous strokes, 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 may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with hepatic impairment should be evaluated for the presence of comorbid conditions such as high blood pressure, heart disease, kidney disease, and asthma, as these may further complicate management and necessitate additional precautions.

Healthcare providers should exercise caution and consider the overall clinical picture when prescribing this medication to patients with compromised liver function.

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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

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

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding 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 taking blood thinners 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 those recommended.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that includes a lot number and expiration date, which can be found on the bottom of the box. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

Patients should be advised on the appropriate route, method, and frequency of administration, which includes repeating doses every 6-8 hours as needed, without exceeding four doses in a 24-hour period.

Clinicians should counsel patients to take the medication with food or milk if stomach upset occurs. They should instruct caregivers to seek medical attention if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, caregivers should be alert for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. If the child does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, they should also consult a healthcare professional.

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.