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Niacin

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This product has been discontinued

Active ingredient
Niacin 500–1000 mg
Other brand names
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 2018
Label revision date
June 20, 2019
FDA Insert
Prescribing information, PDF file
Active ingredient
Niacin 500–1000 mg
Other brand names
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 2018
Label revision date
June 20, 2019
Manufacturer
Jubilant Cadista Pharmaceuticals Inc.
Registration number
ANDA209156
NDC roots
59746-380, 59746-381, 59746-387
FDA Insert
Prescribing information, PDF file
Packaging Info (11 NDCs)
Packaging & NDC Codes (11)

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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 is classified as an antihyperlipidemic agent, meaning it works to lower elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), while also 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. Niacin may work by affecting how the body processes fats, including reducing the production of certain types of cholesterol in the liver and enhancing the removal of triglycerides from the bloodstream.

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 attacks and high cholesterol, these tablets can also reduce the risk of having another nonfatal heart attack. When combined with a bile acid binding resin, niacin can help slow down the progression or even promote the regression of atherosclerotic disease in those with coronary artery disease (CAD) and high cholesterol. Additionally, it can be used alongside a healthy diet to lower elevated TC and LDL-C in adults with primary hyperlipidemia, as well as to reduce TG in adults 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. Your initial dose should be 500 mg, and you should not increase it by more than 500 mg every four weeks.

Once your body is accustomed to the medication, your maintenance dose can range from 1,000 mg to 2,000 mg taken once daily. However, it's crucial to remember that doses greater than 2,000 mg per day are not recommended. Always follow your healthcare provider's instructions to ensure safe and effective use of this medication.

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 have a known hypersensitivity (allergic reaction) to any of the components in the product. It's important to discuss your medical history with your healthcare provider to ensure this medication is safe for you.

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. Myopathy, a condition that affects muscle tissue, has been reported, particularly in older adults or those with diabetes, kidney issues, or thyroid problems, especially if they are also taking statins.

Additionally, liver enzyme levels may rise, so monitoring is necessary before and during treatment. If you have unstable angina or are in the acute phase of a heart attack, use this medication with caution. 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 or after any dose changes. Be cautious if you have active liver disease, peptic ulcers, arterial bleeding, or known allergies to any components of the medication.

Warnings and Precautions

It's important to be aware of some serious risks when using niacin. If you are switching from immediate-release niacin to sustained-release niacin, be cautious, as this can lead to severe liver damage (hepatotoxicity). Additionally, if you are elderly, have diabetes, kidney failure, or uncontrolled hypothyroidism, you may be at a higher risk for muscle problems (myopathy) and a serious condition called rhabdomyolysis.

You should have your liver enzymes checked before starting niacin and monitored regularly during treatment, as persistent elevations can occur. If you have unstable angina (chest pain) or are in the acute phase of a heart attack (MI), use niacin with caution. Also, be aware that niacin can raise blood sugar levels, so if you have diabetes or are at risk, closely monitor your glucose levels, especially during the first few months of treatment or when adjusting your dose.

If you experience severe muscle pain, weakness, or any signs of liver problems, such as yellowing of the skin or eyes, stop using niacin immediately and contact your doctor. If you have chest pain or other severe symptoms, seek emergency help right away.

Overdose

If you suspect an overdose, it's important to take immediate action. Supportive measures, which are steps taken to help manage the situation, 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 contact a healthcare professional or call emergency services to ensure you receive the appropriate care. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware of the potential risks associated with niacin (a vitamin often used to manage cholesterol levels). Niacin is classified as Pregnancy Category C, which means that while animal studies haven't been conducted, there is not enough information to determine its safety for pregnant women. Specifically, it is unclear whether niacin can harm a developing fetus or affect reproductive health.

If you are taking niacin for high cholesterol and find out you are pregnant, you should stop taking the medication. For those using niacin to manage high triglycerides, it's essential to discuss with your healthcare provider whether to continue treatment, as they will help weigh the benefits and risks based on your individual situation. Always consult your doctor before making any changes to your medication during pregnancy.

Lactation Use

Niacin does pass into breast milk, but we don't know the exact amount that a nursing infant might receive. Because high doses of niacin can potentially cause serious side effects in infants, it's important for you to consider whether to continue breastfeeding or to stop taking the medication. This decision should weigh the significance of the drug for your health against the potential risks to your baby.

Currently, there are no studies specifically examining the effects of niacin in breastfeeding mothers, so it's essential to discuss your situation with your healthcare provider to make the best choice for both you and your child.

Pediatric Use

When considering niacin therapy for your child, it's important to know that its safety and effectiveness have not been established for children aged 16 years and younger. This means that there isn't enough research to confirm that niacin is safe or works well for kids in this age group. Always consult with your child's healthcare provider before starting any new treatment to ensure it is appropriate for their specific needs.

Geriatric Use

In clinical studies involving niacin, about 21% of participants were aged 65 and older. Overall, there were no significant differences in safety and effectiveness between older adults and younger patients. However, it's important to note that some older individuals may be more sensitive to the medication, even if this hasn't been widely observed in clinical experiences.

As you consider niacin for yourself or an older loved one, it's reassuring to know that it has been tested in older populations. Still, always consult with a healthcare provider to ensure the dosage and treatment plan are appropriate, taking into account any unique health considerations that may arise with age.

Renal Impairment

If you have kidney problems, it's important to be aware of the potential risks associated with taking niacin. 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, please consult your healthcare provider for guidance on the appropriate use of niacin and any necessary dosage adjustments or monitoring that may be required to ensure your safety.

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 or not function properly.

To ensure your safety, your doctor will likely recommend monitoring your liver enzymes, which are substances that indicate how well your liver is working. These tests should be done before you start treatment and regularly during your therapy to check for any persistent increases in liver enzymes. Always discuss any concerns with your healthcare provider to manage your treatment effectively.

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 (a vitamin that can also help manage cholesterol levels) together may 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 4-6 hours before taking niacin. This timing helps prevent any potential interactions. Always consult with 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 in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it within the recommended limits for optimal safety and effectiveness.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and proper function. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

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), apolipoprotein B (Apo B), 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 three strengths: 500 mg, 750 mg, and 1,000 mg.

How should Niacin extended-release tablets be taken?

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 taking statins or those with certain health conditions.

Can Niacin extended-release tablets be used during pregnancy?

Niacin is classified as Pregnancy Category C, meaning its safety in pregnant women has not been established. If you become pregnant while taking it, you should consult your doctor.

Is Niacin extended-release safe for nursing mothers?

Niacin is excreted in human milk, and due to potential serious adverse reactions in nursing infants, a decision should be made whether to continue nursing or discontinue the drug.

What should be monitored while taking Niacin extended-release tablets?

Liver enzymes should be monitored before and during treatment, as persistent elevations in hepatic transaminase can occur.

What are the contraindications for using Niacin extended-release tablets?

Contraindications include active liver disease, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the product components.

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 USP contain niacin USP, an antihyperlipidemic agent effective at therapeutic doses. Niacin USP, also known as nicotinic acid or 3-pyridinecarboxylic acid, appears as white crystals or a crystalline powder. It is freely soluble in boiling water and in solutions of alkali hydroxides and carbonates, sparingly soluble in water, and practically insoluble in ether. The structural formula of niacin is provided in the documentation.

These unscored, film-coated tablets are light orange to orange in color and are intended for oral administration. They are available in three strengths: 500 mg, 750 mg, and 1,000 mg of niacin. The formulation includes inactive ingredients such as ferric oxide red, ferric oxide yellow, FD&C yellow #6 aluminum lake, hypromellose, povidone, polyethylene glycol, stearic acid, and titanium dioxide. The USP dissolution test for this product is currently pending.

Uses and Indications

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

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.

When used in combination with a bile acid binding resin, niacin extended-release tablets are indicated to slow the progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. Additionally, it serves as an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia.

Furthermore, niacin extended-release tablets 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 are to be administered orally at bedtime, accompanied by a low-fat snack to enhance tolerability. The initial dose should be set at 500 mg once daily to minimize the risk of side effects during the early stages of therapy. Subsequent dose adjustments may be made, with increments not exceeding 500 mg every four weeks.

The recommended maintenance dose ranges from 1,000 mg to 2,000 mg once daily. It is important to note that doses exceeding 2,000 mg daily are not advised. Careful monitoring of the patient's response and tolerance to the medication is essential throughout the treatment process.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with active liver disease, including those with unexplained persistent elevations in hepatic transaminase levels, due to the potential for exacerbation of liver function.

Individuals with active peptic ulcer disease, as the product may aggravate the condition.

Patients experiencing arterial bleeding, where the use of this product could pose significant risks.

Those with known hypersensitivity to any components of the product, to prevent adverse 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, 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 statins. It is essential to assess the risk factors in these populations and consider alternative therapies if necessary.

Monitoring liver enzyme levels is critical, as persistent elevations in hepatic transaminases can occur during treatment. Liver enzymes should be evaluated prior to initiating therapy and periodically throughout treatment to detect any abnormalities early.

Caution is advised when administering niacin to patients with unstable angina or during the acute phase of a myocardial infarction (MI). The potential for exacerbating these conditions necessitates careful consideration of the risk-to-benefit ratio in such patients.

Niacin has the potential to elevate 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 therapy or following any dose adjustments. Regular monitoring will help manage any potential hyperglycemia effectively.

Side Effects

Patients may experience a range of adverse reactions while using this 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, 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. Persistent elevations in hepatic transaminase levels can occur, necessitating monitoring of liver enzymes before and during treatment. Caution is advised when administering this medication to patients with unstable angina or during the acute phase of a myocardial infarction (MI).

Additionally, niacin can elevate 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.

Other important considerations include the presence of active liver disease, which may manifest as unexplained persistent elevations in hepatic transaminase levels, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the components of the product.

Drug Interactions

Caution is advised when co-administering niacin with statins, as this combination may elevate the risk of myopathy and rhabdomyolysis. Clinicians should consider monitoring for signs of muscle-related adverse effects in patients receiving both therapies.

Bile acid sequestrants possess a high binding capacity for niacin, which may reduce the efficacy of niacin when taken concurrently. It is recommended that bile acid sequestrants be administered at least 4 to 6 hours prior to niacin to minimize this interaction and ensure optimal therapeutic outcomes.

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

Safety and effectiveness of niacin therapy in pediatric patients aged 16 years and younger have not been established. Therefore, caution is advised when considering the use of niacin in this population. Further studies are needed to determine appropriate dosing and potential outcomes in children and adolescents.

Geriatric Use

In clinical studies of niacin, 21% of the 979 patients evaluated were aged 65 years and older. No overall differences in safety and effectiveness were observed between elderly patients and their younger counterparts. However, it is important to note that while other reported clinical experiences have not identified significant differences in responses between geriatric patients and younger individuals, the possibility of greater sensitivity in some older adults cannot be excluded.

Healthcare providers should exercise caution when prescribing niacin to elderly patients, considering the potential for increased sensitivity. Monitoring for adverse effects and therapeutic response is recommended to ensure optimal safety and efficacy in this population.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with niacin or niacin extended-release tablets. The effects of niacin extended-release tablets on fetal outcomes are not well established, and it is unknown whether these medications can cause fetal harm when administered to pregnant women or affect reproductive capacity.

If a woman receiving niacin for primary hyperlipidemia becomes pregnant, the drug should be discontinued. In cases where a woman being treated with niacin for hypertriglyceridemia conceives, the benefits and risks of continued therapy should be assessed on an individual basis. Healthcare professionals are advised to consider these factors when managing treatment in pregnant patients.

Lactation

Niacin is excreted into human milk; however, the actual dose received by breastfed infants or the percentage of the maternal dose is not known. Due to the potential for serious adverse reactions in nursing infants from lipid-altering doses of nicotinic acid, healthcare professionals should consider whether to discontinue nursing or to discontinue the drug, weighing the importance of the medication to the mother. No studies have been conducted to evaluate the effects of niacin in nursing mothers.

Renal Impairment

Patients with renal impairment may experience an increased risk of myopathy and rhabdomyolysis when taking niacin. This risk is particularly heightened in elderly patients, those with diabetes, and individuals with uncontrolled hypothyroidism. Additionally, patients with reduced kidney function who are concurrently treated with a statin should be closely monitored due to the potential for exacerbated adverse effects. It is advisable for healthcare professionals to consider these factors when prescribing niacin to patients with renal impairment and to implement appropriate dosing adjustments and monitoring protocols as necessary.

Hepatic Impairment

Patients with hepatic impairment may experience severe hepatic toxicity when substituting sustained-release niacin for immediate-release niacin at equivalent doses. Due to the potential for liver enzyme abnormalities, it is essential to monitor liver enzymes before and during treatment. Persistent elevations in hepatic transaminases may occur, necessitating careful evaluation of liver function throughout the course of therapy. Adjustments to dosing or treatment regimens should be considered based on the patient's liver function status and the results of liver enzyme monitoring.

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, it is crucial to monitor the patient closely for any signs of adverse reactions.

Management procedures should include immediate assessment of the patient's vital signs and overall clinical status. Supportive care may involve maintaining airway patency, ensuring adequate ventilation, and providing hemodynamic support as necessary.

Healthcare providers are advised to consult local poison control centers or relevant toxicology resources for guidance on specific interventions and treatments tailored to the substance involved in the overdose. Prompt recognition and appropriate management are essential to mitigate potential complications associated with overdose situations.

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 3,000 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 comprehensive studies have been conducted regarding the potential for carcinogenesis, mutagenesis, or impairment of fertility associated with niacin.

Postmarketing Experience

Postmarketing experience has identified cases of hepatotoxicity associated with the use of niacin, particularly in patients with pre-existing liver disease or those taking high doses. Reports of myopathy and rhabdomyolysis have been received, especially in patients taking niacin in combination with statins. Additionally, there have been cases of gastrointestinal bleeding reported in patients taking niacin, particularly in those with a history of peptic ulcer disease.

Instances of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Furthermore, reports indicate elevated blood glucose levels in patients with diabetes mellitus using niacin, which necessitates monitoring and potential adjustment of diabetes medications.

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.

Niacin tablets should be taken at bedtime, following a low-fat snack, as administration on an empty stomach is not recommended. Patients should be instructed to swallow the tablets whole and not to break, crush, or chew them. In the event of an interruption in dosing, patients should contact their physician prior to restarting therapy, as re-titration is recommended.

Patients must promptly notify their physician of any unexplained muscle pain, tenderness, or weakness. They should also discuss all medications, 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. 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 niacin at bedtime, patients may experience flushing primarily 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 may take aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before taking niacin. Additionally, they should avoid alcohol, hot beverages, and spicy foods around the time of niacin administration. 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity 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 Jubilant Cadista Pharmaceuticals Inc.. 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 (ANDA209156) 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.