Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
March 23, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
March 23, 2026
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
ANDA217261
NDC root
51672-2146
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 concentrated oral suspension designed for infants aged 6 months to 23 months. It is a nonsteroidal anti-inflammatory drug (NSAID) that helps reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headaches, and toothaches. This dye-free and alcohol-free medication comes in a pleasant berry flavor, making it easier for young children to take.

When used as directed, ibuprofen can provide relief for up to 8 hours, helping to keep your little one comfortable during times of discomfort. Always use the enclosed syringe for accurate dosing.

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, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

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

To find the right dose for your child, refer to the dosing chart. If possible, use your child's weight for the most accurate measurement; otherwise, you can use their age. For measuring, use the dosing device that comes with the product—do not use any other measuring tools. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to give more than four doses in a single day.

For children under 6 months, it's best to consult a doctor before administering this medication. For children weighing between 12 to 17 pounds (6-11 months), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12-23 months), the dose is 1.875 mL.

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 allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or symptoms of heart problems (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

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 rash, stop using the medication 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 or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should not use ibuprofen for more than two days in children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center immediately at 1-800-222-1222. Stop using ibuprofen and call your doctor if your child experiences any signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or weakness), or if their condition does not improve within 24 hours. Additionally, seek medical advice if fever or pain worsens or lasts more than three days, or if any new symptoms arise.

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 planning to become pregnant, it's important to be cautious with medications. The information provided does not specify any safety concerns, dosage changes, or special precautions for using ibuprofen during pregnancy. This means that there is no clear guidance on its use in this situation.

Before taking ibuprofen or any medication, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual circumstances. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

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 posing 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 giving medication to children. You should not use this medication in children under 3 years of age unless a doctor specifically advises it. For children younger than 6 months, it's essential to consult a doctor before use. If your child is between 6 to 23 months, the recommended doses are 1.25 mL for those weighing 12-17 lbs and 1.875 mL for those weighing 18-23 lbs.

To help prevent stomach upset, consider giving the medication with food or milk. Always check with a doctor if your child has a history of stomach issues, is taking other medications, or has serious health conditions. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately. Remember, do not exceed 4 doses in a day.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it is important to approach any treatment with caution. The insert mainly discusses its use in young children, particularly infants aged 6 to 23 months. Since there are no guidelines or dosage adjustments provided for elderly patients, you should consult with a healthcare professional before starting this medication. They can help ensure that it is safe and appropriate for your individual health needs. Always prioritize open communication with your doctor about any concerns or questions you may have regarding medications.

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 high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

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 is crucial to ensure that the medication is safe and effective for you.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have to receive the best care possible.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, always refer to the bottom panel of the carton for the lot number and expiration date to confirm that the product is still valid for use. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, 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 reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group is Ibuprofen suitable for?

Ibuprofen is suitable for infants aged 6 months to 23 months.

How should I measure the dose of Ibuprofen?

Use the enclosed syringe to measure the dose. Do not use any other device.

What are the recommended doses for infants?

For infants weighing 12-17 lbs (6-11 months), the dose is 1.25 mL. For those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

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

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

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if your child has ever had an allergic reaction to it or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

What should I do if my child has a severe sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

Can I give Ibuprofen to my child more than 4 times a day?

No, do not use Ibuprofen more than 4 times a day.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Is there any specific information regarding the use of Ibuprofen during pregnancy or breastfeeding?

The provided information does not mention any specific warnings or recommendations for the use of Ibuprofen during pregnancy or breastfeeding.

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

No description information is available for the specified drug.

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, sore throat, headaches, and toothaches.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should ensure that the appropriate dosage is administered based on the child's weight or age, as outlined in the dosing chart below.

Prior to administration, the product must be shaken well. The dosing device provided should be used to measure the liquid accurately; no other measuring device should be utilized. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. It is imperative not to exceed the recommended dosage.

Dosing Chart:

  • For infants under 6 months of age, consultation with a physician is required before administration.

  • For infants weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL.

  • For infants weighing 18-23 lbs (12-23 months), the recommended dose is 1.875 mL.

Healthcare professionals should ensure that caregivers are aware of these guidelines to promote safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

NSAIDs, excluding aspirin, are associated with an elevated 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.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if such symptoms occur. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

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

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, further medical consultation is necessary. Caregivers should also be alerted to seek medical advice 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 ibuprofen. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs. The risk of stomach bleeding is heightened if the medication is taken in excess or for prolonged periods.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used beyond the recommended dosage or duration.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. It is advised to discontinue use and consult a healthcare provider if any of the following symptoms occur: faintness, vomiting blood, bloody or black stools, persistent stomach pain, chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

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, medical advice should be sought. Redness or swelling in the painful area or the emergence of new symptoms also warrants consultation with a healthcare professional.

Patients should not use ibuprofen if they have a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, or if they are scheduled for heart surgery. Prior to use, it is recommended that patients consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for those taking diuretics or under medical care for serious conditions.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 3 years of age should not use this medication unless directed by a healthcare professional. For infants under 6 months, consultation with a doctor is advised prior to use.

Recommended dosing for children is as follows: for those weighing 12-17 lbs (6-11 months), the dosage is 1.25 mL; for children weighing 18-23 lbs (12-23 months), the dosage is 1.875 mL. It is recommended that the medication be taken with food or milk if stomach upset occurs.

Healthcare professionals should be consulted if the pediatric patient has a history of stomach problems, is taking other medications, or has any serious health conditions. Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. The medication should not be administered more than 4 times a day.

Geriatric Use

The prescribing information does not provide specific data regarding the use of this medication in geriatric patients. The focus of the insert is primarily on pediatric use, particularly for infants aged 6 months to 23 months.

As there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of specific guidance in this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of ibuprofen during pregnancy in the provided text. Healthcare professionals should consider the potential risks and benefits when prescribing ibuprofen to pregnant patients, as the absence of data does not imply safety. It is advisable to exercise caution and evaluate the necessity of treatment on a case-by-case basis, particularly during the third trimester, when nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with adverse fetal outcomes. Women of childbearing potential should be informed of the lack of specific safety data and encouraged to discuss any concerns with their healthcare provider.

Lactation

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

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, 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 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 a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment plan based on the individual patient's liver function and overall health profile.

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 support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including heart attack and stroke, have also been reported in association with the use of NSAIDs. Furthermore, instances of liver enzyme elevations and liver failure have been noted. Serious allergic reactions, including angioedema and anaphylaxis, have been observed in patients taking ibuprofen.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should 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 healthcare providers to encourage patients to consult a doctor before use if any of the following conditions apply to their child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, insufficient fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Additionally, patients should be advised to inform their healthcare provider if the child is taking a diuretic.

Healthcare providers should recommend that patients ask a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Patients should be instructed to stop using the medication and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also seek medical attention if the child shows symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients should be advised to contact their healthcare provider.

Storage and Handling

The product is supplied in a carton that contains a bottle, with specific handling instructions to ensure safety and efficacy. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F).

Healthcare professionals should not use the product if the carton has been opened or if the bottle wrap, which is imprinted with "SEALED FOR SAFETY," is broken or missing. For traceability, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.