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Niacin

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Active ingredient
Niacin 500–1000 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
January 8, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Niacin 500–1000 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
January 8, 2024
Manufacturer
AvPAK
Registration number
ANDA203578
NDC roots
50268-584, 50268-586
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Niacin extended-release tablets contain niacin (also known as nicotinic acid), which is a medication used to help manage cholesterol levels in the body. It works as an antihyperlipidemic agent, meaning it helps to lower elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C). This medication is typically prescribed for individuals with primary hyperlipidemia (high cholesterol) and mixed dyslipidemia, as well as for those with a history of heart attacks to reduce the risk of future heart issues.

In addition to its cholesterol-lowering effects, niacin extended-release tablets can be used alongside other treatments to slow the progression of atherosclerotic disease in patients with coronary artery disease. It is available in two strengths: 500 mg and 1000 mg, and is taken as part of a broader approach to managing cholesterol levels, which may include dietary changes.

Uses

Niacin extended-release tablets are used to help manage cholesterol levels in your body. They can lower high total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while also increasing high-density lipoprotein cholesterol (HDL-C) in individuals with primary hyperlipidemia and mixed dyslipidemia.

If you have a history of heart issues, such as a nonfatal heart attack, these tablets can also help reduce the risk of having another one. Additionally, when taken alongside a bile acid binding resin, niacin can slow down the progression or even help reverse atherosclerotic disease (a condition where arteries become narrowed due to plaque buildup) in patients with coronary artery disease (CAD) and high cholesterol. For adults with primary hyperlipidemia, niacin serves as an important addition to a healthy diet to lower elevated TC and LDL-C levels, and it can also effectively reduce TG in those with severe hypertriglyceridemia.

Dosage and Administration

When you start taking niacin extended-release tablets, it's important to take them at bedtime along with a low-fat snack. This helps your body adjust to the medication and can reduce side effects. You will begin with a dose of 500 mg, and you should not increase this dose by more than 500 mg every four weeks. The typical maintenance dose ranges from 1000 mg to 2000 mg once a day, but remember that doses higher than 2000 mg daily are not recommended.

Make sure to follow this dosing schedule closely to ensure the best results while minimizing any potential side effects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

What to Avoid

You should avoid using this medication if you have active liver disease, which may be indicated by unexplained persistent increases in liver enzymes. Additionally, do not take it if you have active peptic ulcer disease, are experiencing arterial bleeding, or are known to be hypersensitive to any of the product's components. It's important to follow these guidelines to ensure your safety and well-being. If you have any questions or concerns about your health or this medication, please consult your healthcare provider.

Side Effects

You may experience some common side effects while taking this medication, including flushing, diarrhea, nausea, vomiting, increased cough, and itching (pruritus). It's important to be aware of more serious reactions as well. Severe liver toxicity can occur, especially if you switch from immediate-release to sustained-release niacin at the same dose. Additionally, myopathy (muscle weakness) has been reported, particularly in older adults or those with certain health conditions like diabetes or kidney issues, especially if they are also taking statins. Regular monitoring of liver enzymes is recommended, as persistent elevations can happen.

Use this medication cautiously if you have unstable angina or are in the acute phase of a heart attack. It can also raise blood sugar levels, so if you have diabetes or are at risk, your glucose levels should be closely monitored, especially during the initial months of treatment. This medication is not suitable for individuals with active liver disease, peptic ulcers, arterial bleeding, or known allergies to its components.

Warnings and Precautions

It's important to be aware of some serious risks when using niacin extended-release. There have been cases of severe liver damage (hepatotoxicity) in patients who switched from immediate-release niacin to sustained-release niacin at the same doses. Additionally, myopathy (muscle pain or weakness) has been reported, especially in older adults or those with conditions like diabetes, kidney failure, or uncontrolled thyroid issues. If you are taking a statin (a type of cholesterol-lowering medication), your risk for muscle problems may also increase.

Before starting treatment, your doctor will likely monitor your liver enzymes to check for any abnormalities. If you have unstable angina (chest pain due to heart problems) or are in the acute phase of a heart attack, use niacin extended-release with caution. This medication can also raise blood sugar levels, so if you have diabetes or are at risk for diabetes, it's crucial to monitor your glucose levels closely, especially during the first few months of treatment or when your dose changes.

If you experience severe muscle pain, weakness, or any signs of liver problems, such as yellowing of the skin or eyes, stop using niacin and call your doctor immediately. Always seek emergency help if you have severe symptoms or concerns about your health.

Overdose

If you suspect an overdose, it's important to take immediate action. Supportive measures, which are steps taken to help you feel better and stabilize your condition, should be initiated right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe an overdose has occurred, seek medical help immediately. It's crucial to get professional assistance to ensure your safety and well-being. Remember, acting quickly can make a significant difference.

Pregnancy Use

If you are planning to become pregnant or are currently pregnant, it's important to discuss your use of niacin extended-release with your healthcare provider. You should consider stopping this medication if you are trying to conceive. If you do become pregnant while taking niacin extended-release, you should stop taking it immediately and contact your healthcare professional for guidance.

Currently, it is unclear whether niacin extended-release could harm your unborn baby. Therefore, having an open conversation with your doctor about your pregnancy plans and any concerns regarding this medication is essential for your health and the health of your baby.

Lactation Use

If you are breastfeeding, it's important to know that you should not use niacin extended-release. Niacin can pass into your breast milk, which means it could affect your baby. If you have a lipid disorder and are breastfeeding, it's essential to discuss your treatment options with your healthcare professional. Together, you can decide whether to take niacin extended-release tablets or continue breastfeeding, but you should not do both. Make sure to talk to your doctor about the best way to feed your baby if you choose to take this medication.

Pediatric Use

It's important to note that there have been no studies on how this medication works in children aged 16 years and younger. This means that we don't have specific information about how the drug is absorbed, distributed, metabolized, or eliminated in this age group. As a parent or caregiver, you should be aware of this lack of data when considering this medication for your child. Always consult with your child's healthcare provider to discuss the best treatment options and any potential risks.

Geriatric Use

As you or your loved ones age, it's important to be aware that there haven't been specific studies on how this medication works in people over 65 years old. This means that the effects and safety of the drug in older adults are not fully understood.

If you are considering this medication for yourself or an older adult, it's essential to discuss any concerns with a healthcare provider. They can help determine the best approach, taking into account individual health needs and any potential risks.

Renal Impairment

If you have kidney problems, it's important to be aware of the potential risks associated with taking niacin extended-release. Myopathy, which is muscle weakness or pain, has been reported in some patients using this medication. The risk of developing myopathy or a more severe condition called rhabdomyolysis (a serious breakdown of muscle tissue) is higher for certain groups, including older adults, those with diabetes, individuals with renal failure (kidney failure), and patients with uncontrolled hypothyroidism.

If you fall into any of these categories, it's crucial to discuss your treatment plan with your healthcare provider. They may need to adjust your dosage or monitor you more closely to ensure your safety while using niacin.

Hepatic Impairment

If you have liver problems, it's important to be aware of the potential risks associated with certain medications. For instance, switching from immediate-release niacin to sustained-release niacin at the same dose can lead to severe liver toxicity. This means that your liver may become damaged, which can be serious.

To ensure your safety, your doctor will likely recommend monitoring your liver enzymes (substances that indicate liver function) before starting treatment and during your therapy. Persistent elevations in these enzymes can occur, so regular check-ups are essential to keep track of your liver health while on medication. Always discuss any concerns with your healthcare provider to ensure the best care for your liver condition.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you are taking statins (medications used to lower cholesterol), using niacin alongside them can increase the risk of muscle problems, such as myopathy or rhabdomyolysis. This is why it's crucial to discuss all your medications with your healthcare provider to ensure your safety.

Additionally, if you are using bile acid sequestrants (medications that help lower cholesterol by binding bile acids), you should take them at least 4 to 6 hours before taking extended-release niacin. This timing helps prevent any potential interactions. Always consult your healthcare provider about your medications and any lab tests to avoid complications and ensure effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F), which is considered a controlled room temperature according to the United States Pharmacopeia (USP). This helps maintain the product's effectiveness and safety.

When handling the product, be mindful that it is dispensed in Blister Punch Material, which is designed to protect it. Always ensure that you are in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is niacin extended-release tablets used for?

Niacin extended-release tablets are used to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

What are the available strengths of niacin extended-release tablets?

Niacin extended-release tablets are available in two strengths: 500 mg and 1000 mg.

How should I take niacin extended-release tablets?

You should take niacin extended-release tablets at bedtime with a low-fat snack to help reduce side effects.

What is the recommended starting dose for niacin extended-release tablets?

The therapy should be initiated at 500 mg at bedtime, and the dose should not be increased by more than 500 mg in any four-week period.

What are the common side effects of niacin extended-release tablets?

Common side effects include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

Are there any serious risks associated with niacin extended-release tablets?

Yes, severe hepatic toxicity and myopathy have been reported, especially in patients with certain risk factors like diabetes or those taking statins.

Can I take niacin extended-release tablets if I am pregnant?

If you become pregnant, you should stop taking niacin extended-release and consult your healthcare professional, as it is not known if it will harm your unborn baby.

Is niacin extended-release safe to use while breastfeeding?

Niacin can pass into breast milk, so you should discuss with your doctor whether to take niacin extended-release or breast-feed.

What should I do if I have liver disease?

You should not take niacin extended-release tablets if you have active liver disease or unexplained persistent elevations in liver enzymes.

What are the storage conditions for niacin extended-release tablets?

Store niacin extended-release tablets at 20° to 25°C (68° to 77°F) and keep them in their original blister packaging.

Packaging Info

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

FDA Insert (PDF)

This is the full prescribing document for Niacin, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Niacin extended-release tablets contain niacin, USP, which functions as an antihyperlipidemic agent at therapeutic doses. Niacin, also known as nicotinic acid or 3-pyridinecarboxylic acid, is presented as a white, crystalline powder that is highly soluble in water. The tablets are unscored, film-coated, and intended for oral administration, available in two strengths: 500 mg and 1000 mg of niacin.

The 500 mg tablets are light orange to orange, round in shape, and are debossed with ‘AN 321’ on one side, while the reverse side is plain. The 1000 mg tablets are light orange to orange, capsule-shaped, and are debossed with ‘AN 323’ on one side, with the opposite side remaining plain. In addition to niacin, the extended-release tablets contain several inactive ingredients, including FD&C yellow #6/sunset yellow FCF aluminum lake, hydroxyethyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 400, stearic acid, and titanium dioxide.

Uses and Indications

Niacin extended-release tablets are indicated for the following uses:

Niacin extended-release tablets are indicated to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

This medication is also indicated to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. In combination with a bile acid binding resin, niacin extended-release tablets may slow the progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia.

As an adjunct to diet, niacin extended-release tablets are indicated to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. Additionally, they are indicated to reduce TG in adult patients with severe hypertriglyceridemia.

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

Dosage and Administration

Niacin extended-release tablets should be administered at bedtime, accompanied by a low-fat snack to enhance tolerability. The initial dose for therapy should be set at 500 mg once daily at bedtime, which is essential for minimizing the incidence and severity of side effects that may arise during the early stages of treatment.

The dosage may be increased by no more than 500 mg at four-week intervals, allowing for a gradual adjustment to the patient's needs. The recommended maintenance dose ranges from 1000 mg to 2000 mg once daily. It is important to note that doses exceeding 2000 mg daily are not recommended.

Contraindications

Use of this product is contraindicated in the following conditions:

Patients with active liver disease, including those with unexplained persistent elevations in hepatic transaminase levels, should not use this product due to the potential for exacerbating liver dysfunction.

Active peptic ulcer disease is another contraindication, as the product may aggravate gastrointestinal conditions.

The presence of arterial bleeding contraindicates use, given the risk of worsening bleeding complications.

Additionally, individuals with known hypersensitivity to any components of the product should avoid its use to prevent allergic reactions.

Warnings and Precautions

Severe hepatic toxicity has been reported in patients who substitute sustained-release niacin for immediate-release niacin at equivalent doses. Healthcare professionals should exercise caution when making such substitutions and closely monitor patients for signs of liver dysfunction.

Myopathy has been observed in patients taking niacin extended-release formulations. The risk of developing myopathy and rhabdomyolysis is particularly heightened in elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, as well as in patients concurrently treated with statins. It is imperative to assess the patient's overall health status and medication regimen prior to initiating treatment with niacin extended-release.

Monitoring liver enzyme levels is essential, as persistent elevations in hepatic transaminases may occur during treatment. Healthcare providers should conduct baseline liver enzyme tests and continue to monitor these levels throughout the course of therapy to detect any abnormalities early.

Caution is advised when prescribing niacin extended-release to patients with unstable angina or during the acute phase of a myocardial infarction (MI). The potential for exacerbating these conditions necessitates careful evaluation and monitoring.

Additionally, niacin extended-release can lead to increased serum glucose levels. Therefore, glucose levels should be closely monitored in diabetic patients or those at risk of developing diabetes, particularly during the initial months of treatment or following any dose adjustments. Regular monitoring will help mitigate the risk of hyperglycemia and ensure appropriate management of blood glucose levels.

Side Effects

Patients may experience a range of adverse reactions while using the medication. The most common adverse reactions reported include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

Severe adverse reactions have also been observed. Notably, severe hepatic toxicity has occurred in patients who substituted sustained-release niacin for immediate-release niacin at equivalent doses. Myopathy has been reported in patients taking niacin extended-release, with an increased risk for myopathy and rhabdomyolysis particularly among elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, and patients concurrently treated with a statin. Additionally, persistent elevations in hepatic transaminase levels can occur, necessitating monitoring of liver enzymes before and during treatment.

It is important to use this medication with caution in patients with unstable angina or during the acute phase of a myocardial infarction (MI). Niacin extended-release may also increase serum glucose levels; therefore, glucose levels should be closely monitored in diabetic or potentially diabetic patients, especially during the initial months of treatment or following dose adjustments.

Contraindications for this medication include active liver disease, which may manifest as unexplained persistent elevations in hepatic transaminase levels, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to any components of the product.

Drug Interactions

Caution is advised when prescribing niacin in conjunction with statins due to the potential increased risk of myopathy and rhabdomyolysis. Clinicians should monitor patients closely for signs of muscle-related adverse effects and consider dosage adjustments as necessary.

Bile acid sequestrants possess a high binding capacity for niacin. Therefore, it is recommended that these agents be administered at least 4 to 6 hours prior to the administration of niacin extended-release formulations to minimize the risk of reduced efficacy of niacin.

Packaging & NDC

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

Pediatric Use

Pediatric patients aged 16 years and younger have not been studied in pharmacokinetic trials. Therefore, there is limited information regarding the pharmacokinetics of this medication in this population. Healthcare professionals should consider this lack of data when prescribing to pediatric patients and monitor for efficacy and safety accordingly.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not been the subject of pharmacokinetic studies for this medication. As a result, there is limited information regarding the drug's absorption, distribution, metabolism, and excretion in this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to the drug. Close monitoring for efficacy and adverse effects is recommended in this demographic, as individual responses may vary significantly.

Due to the absence of specific data, dosage adjustments may be necessary based on clinical judgment and the patient's overall health status. It is essential to evaluate the risks and benefits of treatment in elderly patients, particularly in the context of comorbidities and concurrent medications.

Pregnancy

Pregnant patients and those planning to conceive should engage in discussions regarding future pregnancy plans with their healthcare professionals. It is important for patients to be advised to discontinue niacin extended-release if they become pregnant and to promptly inform their healthcare provider. Currently, there is insufficient data to determine whether niacin extended-release poses a risk to the unborn baby. Therefore, women of childbearing potential should consult their healthcare provider if they are pregnant or intend to become pregnant while on niacin extended-release therapy.

Lactation

Women who are breastfeeding should be advised against the use of niacin extended-release. Niacin can pass into breast milk, and therefore, lactating mothers should consult with their healthcare professional to discuss options if they have a lipid disorder. It is important for the mother and her doctor to make a decision regarding the use of niacin extended-release tablets in conjunction with breastfeeding, as it is not recommended to do both. Mothers should seek guidance on the best feeding practices for their infants if they choose to take niacin extended-release tablets.

Renal Impairment

Patients with renal impairment may experience an increased risk of myopathy and rhabdomyolysis when taking niacin extended-release. This risk is particularly heightened in elderly patients, those with diabetes, and individuals with uncontrolled hypothyroidism. Careful monitoring is advised for patients with reduced kidney function, especially when niacin is used in conjunction with statins. Dosing adjustments may be necessary based on the patient's renal status to mitigate these risks.

Hepatic Impairment

Patients with hepatic impairment may experience severe hepatic toxicity when substituting sustained-release niacin for immediate-release niacin at equivalent doses. It is essential to monitor liver enzymes, as persistent elevations in hepatic transaminases can occur. Therefore, liver function should be assessed before initiating treatment and periodically during therapy to ensure patient safety and to manage any potential adverse effects related to liver function.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals implement supportive measures to manage the patient's condition effectively.

Potential symptoms of overdose may vary depending on the specific substance involved; however, general signs may include altered mental status, cardiovascular instability, and respiratory distress.

Management of an overdose should focus on stabilizing the patient and addressing any life-threatening symptoms. This may involve monitoring vital signs, providing oxygen support, and administering intravenous fluids as necessary.

Healthcare providers are advised to consult local poison control centers or toxicology experts for guidance on specific antidotes or additional treatment protocols that may be appropriate based on the substance involved in the overdose.

Prompt recognition and intervention are crucial in minimizing the potential complications associated with an overdose.

Nonclinical Toxicology

Niacin administered to mice for a lifetime as a 1% solution in drinking water did not demonstrate carcinogenic potential. The dosage received by the mice was approximately 6 to 8 times the human equivalent of 3000 mg/day, calculated on a mg/m² basis. Additionally, niacin was found to be negative for mutagenicity in the Ames test.

Currently, there are no studies available that assess the effects of niacin on impairment of fertility. Furthermore, no investigations have been conducted regarding the carcinogenicity, mutagenicity, or impairment of fertility associated with niacin extended-release formulations.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included muscle pain, tenderness, or weakness. Additionally, flushing, characterized by warmth, redness, itching, and/or tingling of the skin, has been noted as a common side effect of niacin therapy. This flushing may diminish after several weeks of consistent use of niacin extended-release formulations. The severity of flushing can vary and is more likely to occur at the initiation of therapy or during dose increases.

Patient Counseling

Patients should be advised to adhere to the National Cholesterol Education Program (NCEP) recommended diet, engage in a regular exercise program, and undergo periodic testing of a fasting lipid panel to effectively manage their cholesterol levels. It is important for patients to inform any healthcare professionals prescribing new medications that they are currently taking niacin extended-release.

Niacin extended-release tablets should be taken at bedtime, following a low-fat snack, as administration on an empty stomach is not recommended. Patients must be instructed that these tablets should not be broken, crushed, or chewed; they should be swallowed whole to ensure proper absorption.

In the event of an interruption in dosing, patients should contact their physician prior to restarting therapy, as re-titration of the dosage is recommended. Patients should also be vigilant and notify their physician promptly if they experience any unexplained muscle pain, tenderness, or weakness. It is essential for patients to discuss all medications they are taking, including both prescription and over-the-counter drugs, with their physician.

Flushing, characterized by warmth, redness, itching, and/or tingling of the skin, is a common side effect of niacin therapy. Patients should be informed that this side effect may subside after several weeks of consistent use and is more likely to occur with the initiation of therapy or during dose increases. By taking the medication at bedtime, patients may experience flushing during sleep. If they awaken due to flushing, they should rise slowly, particularly if they feel dizzy or faint, or if they are taking blood pressure medications. Patients should be educated on the symptoms of flushing and how they differ from those of a myocardial infarction.

To minimize flushing, patients should avoid the ingestion of alcohol, hot beverages, and spicy foods around the time of taking niacin extended-release. Additionally, patients should notify their physician if they are taking vitamins or other nutritional supplements that contain niacin or nicotinamide. They should also inform their physician if they experience any symptoms of dizziness or if they are diabetic and notice changes in their blood glucose levels.

Storage and Handling

The product is supplied in a Blister Punch Material configuration. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Niacin as submitted by AvPAK. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (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 Niacin, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA203578) 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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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.