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Equate Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film 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 2016
Label revision date
April 27, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film 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 2016
Label revision date
April 27, 2023
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA077349
NDC root
49035-517
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

Equate™ is a brand of ibuprofen tablets, each containing 200 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication is commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It can also help reduce fever.

In addition to its pain-relieving properties, equate™ is comparable to Motrin® IB, making it a familiar choice for those seeking relief from discomfort associated with conditions like arthritis and the common cold.

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.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

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

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the use of this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals 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 bloody or black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain, difficulty breathing, or weakness on one side of the body. It's important to talk to your doctor if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications, as these factors can increase your risk of adverse effects.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using ibuprofen and contact your doctor. Seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, or if you notice any new symptoms. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial 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 guidance from your doctor.

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 if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to 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 with a doctor before using this medication. For those aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may take two caplets. However, be sure not to exceed six caplets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain health considerations when taking medications. If you are 60 years or older, there is a higher risk of severe stomach bleeding. To help minimize this risk, your healthcare provider will likely recommend using the smallest effective dose of the medication. Always discuss your specific health needs and any concerns with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney disease or other health conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, it's important to be cautious with your medications. Your healthcare provider may need to adjust your dosage or monitor your kidney function closely to ensure your safety and the effectiveness of your treatment.

Always communicate openly with your doctor about your kidney health and any other medical issues you have, as this will help them provide the best care tailored to your needs.

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 monitor your liver function closely. This is to ensure that the medication is safe and effective for you, as liver issues can impact how your body processes certain drugs.

Additionally, if you have other health conditions like high blood pressure, heart disease, kidney disease, or asthma, be sure to discuss these with your doctor. They will consider all your health factors when determining the best treatment plan for you. Always follow your healthcare provider's instructions and attend regular check-ups to monitor your liver health.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and health conditions. For instance, if you are taking aspirin to prevent heart attacks or strokes, using ibuprofen may reduce the effectiveness of aspirin. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), like naproxen or even other forms of aspirin, can increase the risk of stomach bleeding.

If you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, it's crucial to talk to your healthcare provider before using ibuprofen. They can help you understand the risks, especially since using NSAIDs can increase the chances of heart attack, heart failure, and stroke, particularly if taken in higher doses or for extended periods. Always discuss any medications or health concerns with your doctor to ensure your safety.

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 keep it away from high humidity and avoid exposing it to excessive heat, which can occur at temperatures above 40°C (104°F).

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

You can take this medication orally. For adults and children aged 12 and older, the recommended dose is 1 caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may take 2 caplets, but do not exceed 6 caplets in a 24-hour period unless directed by a doctor. For children under 12, consult a doctor for appropriate dosing.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Avoid using it after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is equate™?

Equate™ is an ibuprofen tablet containing 200 mg of ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID) used as a pain reliever and fever reducer.

What conditions does equate™ temporarily relieve?

Equate™ temporarily relieves minor aches and pains due to headache, muscular aches, minor arthritis pain, toothache, backache, the common cold, and menstrual cramps, and it also reduces fever.

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

Adults and children 12 years and older should take 1 caplet every 4 to 6 hours while symptoms persist, and may take 2 caplets if pain or fever does not respond to 1 caplet, but should not exceed 6 caplets in 24 hours unless directed by a doctor.

What should I do if I experience severe allergic reactions?

If you experience symptoms such as hives, facial swelling, or difficulty breathing, stop using equate™ and seek medical help immediately.

Are there any warnings associated with equate™?

Yes, equate™ may cause severe stomach bleeding, especially in individuals over 60, those with a history of stomach ulcers, or those taking blood thinners. It also increases the risk of heart attack and stroke.

What should I do if I have symptoms of stomach bleeding?

If you feel faint, vomit blood, have bloody or black stools, or have persistent stomach pain, stop using equate™ and consult a doctor.

Can I use equate™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using equate™, especially after 20 weeks of pregnancy, as it may cause complications.

What should I do if I overdose on equate™?

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

How should I store equate™?

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

Packaging Info

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

Packaging configurations for Equate Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Tablets are formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 200 mg per tablet. Each bottle contains 100 capsule-shaped tablets designed for oral administration. These tablets serve as a pain reliever and fever reducer, providing effective symptomatic relief.

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 aged 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 any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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. The likelihood of these serious cardiovascular events is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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 ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen carries a significant 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.

Additionally, NSAIDs, including ibuprofen, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having 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, also 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 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

It is recommended that patients consult a healthcare provider prior to using ibuprofen 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. Patients should also inform their healthcare provider if they are taking diuretics, aspirin for cardiovascular protection, or any other medications, as ibuprofen may interfere with the efficacy of aspirin.

Drug Interactions

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

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid concurrent use of ibuprofen and aspirin for these indications.

The concomitant use of ibuprofen with other NSAIDs, whether prescription or nonprescription (such as naproxen), can elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Additionally, the use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, particularly when used in higher doses or for extended periods. It is advisable to limit the duration and dosage of NSAID therapy to the minimum effective amount.

Diuretics Caution is advised when administering ibuprofen to patients who are concurrently taking diuretics. The combination may lead to reduced diuretic efficacy and potential fluid retention. Regular monitoring of renal function and blood pressure is recommended in these patients.

Patient Considerations Patients with a history of gastrointestinal issues, hypertension, cardiovascular disease, liver cirrhosis, kidney disease, or asthma should seek medical advice prior to using ibuprofen. A thorough assessment of the patient's medical history and current medication regimen is essential to mitigate potential risks associated with ibuprofen use.

Packaging & NDC

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

Packaging configurations for Equate Ibuprofen.
Details

Pediatric Use

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

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding. Therefore, it is crucial to exercise caution when prescribing this medication to geriatric patients.

In this population, the smallest effective dose should be utilized to minimize potential adverse effects. Healthcare providers are advised to closely monitor elderly patients for any signs of gastrointestinal bleeding and to consider the overall health status and concurrent medications of these patients when determining the appropriate dosage.

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 at 20 weeks of gestation or later unless specifically directed by a physician, 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, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease. Patients with reduced kidney function may experience altered drug clearance, necessitating modifications to the standard dosing regimen. Regular monitoring of renal function is recommended to ensure safety and efficacy in this population. Additionally, healthcare professionals should remain vigilant for potential complications associated with concurrent conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these may further impact renal function and overall treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary based on the severity of hepatic impairment. Close monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential drug interactions and contraindications, particularly if they also have comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke.

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

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or 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 aged 60 or older, those with a history of stomach ulcers or bleeding problems, or individuals taking anticoagulant or steroid medications. Furthermore, an increased risk of heart attack and stroke has been observed with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, especially when used in excess of the recommended duration or dosage.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult with a doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider before starting this medication.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist before use, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to consult with their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, with temperatures not exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not respond to 1 caplet, 2 caplets may be taken, but the total should not exceed 6 caplets in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is advised before use.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding, particularly noting that ibuprofen should not be used after 20 weeks of pregnancy unless specifically directed by a doctor due to potential risks to the unborn child or complications during delivery. It is also important to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Equate 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 Equate 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.

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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.