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Niacin 1000 mg Tablet, Extended Release, 90-count — NDC 70752-0296-09 package photo
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Niacin 1000 mg Tablet, Extended Release, 90-count — NDC 70752-296-09 (Billing 70752-0296-09)

by QUAGEN PHARMACEUTICALS LLC · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 90 tablets of Niacin 1000 mg Tablet, Extended Release from QUAGEN PHARMACEUTICALS LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 70752-0296-09
🏷️ FDA NDC (as labeled) 70752-296-09 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Niacin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 29, 2026 — Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. (Golden State Medical Supply Inc.) · FDA recall D-0587-2026
Class II · May 27, 2026 — Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. (Lannett Company Inc.) · FDA recall D-0584-2026
Class II · Oct 20, 2025 — Failed Dissolution Specifications (Golden State Medical Supply Inc.) · FDA recall D-0158-2026
Class II · Oct 10, 2025 — Failed Dissolution Specifications (Lannett Company Inc.) · FDA recall D-0096-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70752-296-09
Product NDC 70752-296
11-digit billing NDC 70752029609
RxCUI 1098134, 1098141
UNII 2679MF687A
Application # ANDA203899
SPL Set ID 249e27ac-e1e7-42dc-84f6-cd32fd1d9dee
Established class (EPC) Nicotinic Acid
Chemical class Nicotinic Acids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-06
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance NIACIN
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1098134
Why two NDCs? The FDA registers this code as 70752-296-09 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70752-0296-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nicotinic Acid class.

Pharmacologic class Nicotinic Acid
Drug family (ATC) Nicotinic acid and derivatives, Nicotinic acid and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Niacin is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in your blood and to increase the amount of high density lipoprotein (HDL; ''good cholesterol''). Niacin can be used in a number of situations including the following: alone or in combination with other medications, such as HMG-CoA inhibitors (statins) or bile acid-binding resins; to decrease the risk of another heart attack in patients with high cholesterol who have had a heart attack; to prevent worsening of atherosclerosis (b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You're right that niacin is a B vitamin, but at prescription doses it works as a medicine to improve your blood fat levels. It can lower LDL (bad cholesterol) and triglycerides, an...
  • Why did my doctor prescribe niacin — isn't that just a vitamin?
  • That warmth, redness, and tingling — especially on your face and neck — is the most common side effect of niacin and is called flushing. It can feel alarming the first few times, b...
  • What's that hot, red, flushing feeling — is something wrong?
📖 Read our full Niacin guide →
1
Nutrient depletion considerations

Niacin (prescription drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Niacin (prescription drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70752-0296-09 You're viewing this Main listing 90 TABLET, EXTENDED RELEASE in 1 BOTTLE 2026-08-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Niacin 1000 mg 62135-0498-90 Chartwell 90 tablets $0.326 AB Availability likely —
Niacin 1000 mg 47335-0613-08 Sun 100 tablets — AB FDA listed —
Niacin 1000 mg 59651-0020-05 Aurobindo 500 tablets — AB FDA listed —
Niacin 1000 mg 65162-0323-03 Amneal 30 tablets — AB FDA listed —
Niacin 1000 mg 51407-0268-90 Golden 90 tablets — AB FDA listed —
Niacin 1000 mg 62175-0322-43 Lannett 1000 tablets — AB FDA listed —
Niacin 1000 mgthis 70752-0296-09 QUAGEN 90 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red
ShapeRound
ImprintKU;322
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerQUAGEN PHARMACEUTICALS LLC
Application holderQUAGEN PHARMACEUTICALS LLC
FDA applicationANDA203899 (ANDA)
Labeler code70752
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio50 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.

In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.

Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Limitations of Use Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions ( 5.1 )] . Niacin extended-release tablets contain­ extended-release niacin (nicotinic acid), and are indicated: To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.

( 1 ) To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. ( 1 ) In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. ( 1 ) As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia.

( 1 ) To reduce TG in adult patients with severe hypertriglyceridemia. ( 1 ) Limitations of use: Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. ( 5.1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2.1 ) Dose range: 500 mg to 2000 mg once daily. ( 2.1 ) Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any 4-week period.

( 2.1 ) Maintenance dose: 1000 to 2000 mg once daily. ( 2.2 ) Doses greater than 2000 mg daily are not recommended. ( 2.2 )

2.1Initial Dosing Niacin Extended-release Tablets, USP should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

Table 1. Recommended Dosing Week(s) Daily Dose Niacin Extended-release Tablets Dosage INITIAL TITRATION SCHEDULE 1 to 4 500 mg 1 niacin extended-release tablet 500 mg at bedtime 5 to 8 1000 mg 1 niacin extended-release tablet 1000 mg or 2 niacin extended-release tablets 500 mg at bedtime After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily.

Daily dose should not be increased more than 500 mg in a 4-week period and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men. 1500 mg 3 niacin extended-release tablets 500 mg at bedtime 2000 mg 2 niacin extended-release tablets 1000 mg or 4 niacin extended-release tablets 500 mg at bedtime

2.2Maintenance Dose The daily dosage of niacin extended-release tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended.

Women may respond at lower niacin extended-release tablets doses than men [see Clinical Studies ( 14.2 )] . Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable. Flushing of the skin [see Adverse Reactions ( 6.1 )] may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin extended-release tablets dose).

Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of niacin extended-release tablets ingestion.

Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see Warnings and Precautions ( 5 )] . Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response. If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).

Niacin extended-release tablets should be taken whole and should not be broken, crushed or chewed before swallowing. Niacin extended-release tablets should be taken whole and should not be broken,crushed or chewed before swallowing.

2.3Dosage in Patients with Renal… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS 500 mg unscored, red, round, film-coated, convex tablet debossed with “KU” on one side, “320” on the other side. 1000 mg unscored, red, oval, film-coated, convex tablet debossed with “KU” on one side, “322” on the other side. Unscored film-coated tablets for oral administration: 500 and 1000 mg niacin extended-release. ( 3 )

⛔ Contraindications 93 words ▾

4 CONTRAINDICATIONS Niacin extended-release tablets are contraindicated in the following conditions: Active liver disease or unexplained persistent elevations in hepatic transaminases [see Warnings and Precautions ( 5.3 )] Patients with active peptic ulcer disease Patients with arterial bleeding Hypersensitivity to niacin or any component of this medication [see Adverse Reactions ( 6.1 )] Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 , 5.3 ) Active peptic ulcer disease.

( 4 ) Arterial bleeding. ( 4 ) Known hypersensitivity to product components. ( 4 , 6.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Niacin extended-release tablets preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin extended-release tablets, therapy with niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the niacin extended-release tablets dose should then be titrated to the desired therapeutic response [see Dosage and Administration ( 2.1 )] . Caution should also be used when niacin extended-release tablets are used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.

Niacin is rapidly metabolized by the liver, and excreted through the kidneys. Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic impairment [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] and should be used with caution in patients with renal impairment. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during niacin extended-release tablets therapy.

Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. ( 5.3 ) Myopathy has been reported in patients taking niacin extended-release tablets. The risk for myopathy and rhabdomyolysis are increased among elderly patients; patients with diabetes, renal failure, or uncontrolled hypothyroidism; and patients being treated with a statin.

( 5.2 ) Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur. Monitor liver enzymes before and during treatment. ( 5.3 ) Use with caution in patients with unstable angina or in the acute phase of an MI.

( 5 ) Niacin extended-release tablets can increase serum glucose levels. Glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use or dose adjustment. ( 5.4 )

5.1Mortality and Coronary Heart Disease Morbidity Niacin extended-release tablets have not been shown to reduce cardiovascular morbidity or mortality among patients already treated with a statin. The Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial was a randomized placebo-controlled trial of 3414 patients with stable, previously diagnosed cardiovascular disease. Mean baseline lipid levels were LDL-C 74 mg/dL, HDL-C 35 mg/dL, non-HDL-C 111 mg/dL and median triglyceride level of 163-177 mg/dL.

Ninety-four percent of patients were on background statin therapy prior to entering the trial. All participants received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40-80 mg/dL, and were randomized to receive niacin extended-release tablets 1500-2000 mg/day (n=1718) or matching placebo (IR Niacin, 100-150 mg, n=1696). On-treatment lipid changes at two years for LDL-C were -12.0% for the simvastatin plus niacin extended-release tablets group and -5.5% for the simvastatin plus placebo group.

HDL-C increased by 25.0% to 42 mg/dL in the simvastatin plus niacin extended-release tablets group and by 9.8% to 38 mg/dL in the simvastatin plus placebo group (P<0.001). Triglyceride levels decreased by 28.6% in the simvastatin plus niacin extended-release tablets group and by 8.1% in the simvastatin plus placebo group. The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures.

The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. The pri… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Mortality and Coronary Heart Disease Morbidity [see Warnings and Precautions ( 5.1 ) ] Skeletal Muscle (rhabdomyolysis) [see Warnings and Precautions ( 5.2 ) ] Liver Dysfunction [see Warnings and Precautions ( 5.3 ) ] Laboratory Abnormalities [see Warnings and Precautions ( 5.4 ) ] Most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

( 6.1 ) Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes prior to niacin extended-release tablets dose). ( 2.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1- 888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In the placebo-controlled clinical trials database of 402 patients (age range 21-75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on niacin extended-release tablets and 4% of patients on placebo discontinued due to adverse reactions.

The most common adverse reactions in the group of patients treated with niacin extended-release tablets that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs.

0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%).

The most commonly reported adverse reactions (incidence >5% and greater than placebo) in the niacin extended-release tablets controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus. In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for niacin extended-release tablets. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope.

In pivotal studies, 6% (14/245) of niacin extended-release tablets patients discontinued due to flushing. In comparisons of immediate-release (IR) niacin and niacin extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received niacin extended-release tablets. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR niacin versus 1.9 following niacin extended-release tablets.

Other adverse reactions occurring in 5% of patients treated with niacin extended-release tablets and at an incidence greater than placebo are shown in Table 2 below. Table 2. Treatment-Emergent Adverse Reactions by Dose Level in 5% of Patients and at an Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo-Controlled Clinical Trials Placebo-Controlled Studies Niacin Extended-release Tablets Treatment Pooled results from placebo-controlled studies; for niacin extended-release tablets, n=245 and median treatment duration=16 weeks.

Number of niacin extended-release tablets patients (n) are not additive across doses. Recommended Daily Maintenance Doses Adverse reactions are reported at the initial dose where they occur. Placebo (n = 157) % 500 mg The 500 mg/day dose is outside the recommended daily maintenance dosing range [see Dosage an… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. ( 5.2 , 7.1 ) Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6 hours before niacin extended-release administration. ( 7.2 )

7.1Statins Caution should be used when prescribing niacin (≥1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis [see Warnings and Precautions ( 5 ) and Clinical Pharmacology ( 12.3 )] .

7.2Bile Acid Sequestrants An in vitro study results suggest that the bile acid-binding resins have high niacin binding capacity. Therefore, 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of niacin extended-release tablets [see Clinical Pharmacology ( 12.3 )] .

7.3Aspirin Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear.

7.4Antihypertensive Therapy Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension.

7.5Other Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of niacin extended-release.

7.6Laboratory Test Interactions Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict’s reagent) in urine glucose tests.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Discontinue in patients with hyperlipidemia; assess individual risks and benefits in patients with hypertriglyceridemia. ( 8.1 ) Lactation: Advise patients not to breastfeed during treatment. ( 8.2 ) Renal impairment: Niacin extended-release should be used with caution in patients with renal impairment.

( 5 , 8.6 ) Hepatic impairment: Niacin extended-release is contraindicated in active liver disease or significant or unexplained hepatic dysfunction or unexplained elevations of serum transaminases. ( 4 , 5 , 5.3 , 8.7 )

8.1Pregnancy Risk Summary Discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their healthcare provider of a known or suspected pregnancy.

The potential for embryofetal toxicity with the doses of niacin in niacin extended-release tablets is unknown. The available data on niacin extended-release tablets use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets.

Treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary Niacin is present in human milk and the amount of niacin increases with maternal supplementation. There is no information on the effects of the doses of niacin in niacin extended-release tablets on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, advise patients not to breastfeed during treatment with niacin extended-release tablets.

8.4Pediatric Use Safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established.

8.5Geriatric Use Of 979 patients in clinical studies of niacin extended-release tablets, 21% of the patients were age 65 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6Renal Impairment No studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with renal impairment [see Warnings and Precautions ( 5 )] .

8.7Hepatic Impairment No studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with a past history of liver disease and/or who consume substantial quantities of alcohol. Active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release tablets [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] .

8.8Gender Data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of niacin extended-release tablets.

8.8Gender Data from the clinical trials suggest that women have a greater hypolipidemic response than men at e… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 196 words ▾

8.1Pregnancy Risk Summary Discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their healthcare provider of a known or suspected pregnancy.

The potential for embryofetal toxicity with the doses of niacin in niacin extended-release tablets is unknown. The available data on niacin extended-release tablets use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with niacin or with niacin extended-release tablets.

Treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Of 979 patients in clinical studies of niacin extended-release tablets, 21% of the patients were age 65 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 13 words ▾

10 OVERDOSAGE Supportive measures should be undertaken in the event of an overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

12.3Pharmacokinetics Absorption Due to extensive and saturable first-pass metabolism, niacin concentrations in the general circulation are dose dependent and highly variable. Time to reach the maximum niacin plasma concentrations was about 5 hours following niacin extended-release tablets. To reduce the risk of gastrointestinal (GI) upset, administration of niacin extended-release tablets with a low-fat meal or snack is recommended.

Single-dose bioavailability studies have demonstrated that the 500 mg and 1000 mg tablet strengths are dosage form equivalent but the 500 mg and 750 mg tablet strengths are not dosage form equivalent. Metabolism The pharmacokinetic profile of niacin is complicated due to extensive first-pass metabolism that is dose-rate specific and, at the doses used to treat dyslipidemia, saturable. In humans, one pathway is through a simple conjugation step with glycine to form nicotinuric acid (NUA).

NUA is then excreted in the urine, although there may be a small amount of reversible metabolism back to niacin. The other pathway results in the formation of nicotinamide adenine dinucleotide (NAD). It is unclear whether nicotinamide is formed as a precursor to, or following the synthesis of, NAD.

Nicotinamide is further metabolized to at least N-methylnicotinamide (MNA) and nicotinamide-N-oxide (NNO). MNA is further metabolized to two other compounds, N-methyl-2-pyridone-5-carboxamide (2PY) and N-methyl-4-pyridone-5-carboxamide (4PY). The formation of 2PY appears to predominate over 4PY in humans.

At the doses used to treat hyperlipidemia, these metabolic pathways are saturable, which explains the nonlinear relationship between niacin dose and plasma concentrations following multiple-dose niacin extended-release tablets administration. Nicotinamide does not have hypolipidemic activity; the activity of the other metabolites is unknown. Elimination Following single and multiple doses, approximately 60 to 76% of the niacin dose administered as niacin extended-release tablets was recovered in urine as niacin and metabolites; up to 12% was recovered as unchanged niacin after multiple dosing.

The ratio of metabolites recovered in the urine was dependent on the dose administered. Pediatric Use No pharmacokinetic studies have been performed in this population (£16 years) [see Use in Specific Populations ( 8.4 )] . Geriatric Use No pharmacokinetic studies have been performed in this population (>65 years) [see Use in Specific Populations ( 8.5 )] .

Renal Impairment No pharmacokinetic studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with renal disease [see Warnings and Precautions ( 5 )] . Hepatic Impairment No pharmacokinetic studies have been performed in this population.

Active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release tablets [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . Gender Steady-state plasma concentrations of niacin and metabolites after administration of niacin extended-release tablets are generally higher in women than in men, with the magnitude of the difference varying with dose and metabolite. This gender differences observed in plasma levels of niacin and its metabolites may be due to gender-specific differences in metabolic rate or volume of distribution.

Recovery of niacin and metabolites in urine, h… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

📦 How Supplied / Storage and Handling 87 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Niacin Extended-release Tablets, USP, 500 mg, are unscored, red, round, film-coated, convex tablets debossed with “KU” on one side, “320” on the other side. They are supplied as follows: Bottles of 90 NDC 70752-295-09 Niacin Extended-release Tablets, USP, 1000 mg, are unscored, red, oval, film-coated convex tablets debossed with “KU” on one side, “322” on the other side. They are supplied as follows: Bottles of 90 NDC 70752-296-09 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 103 words ▾

11 DESCRIPTION Niacin Extended-release Tablets, USP (niacin tablet, film-coated extended-release), contain niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula: Niacin extended-release tablets are unscored, red, film-coated tablets for oral administration and are available in two tablet strengths containing 500 and 1000 mg niacin. Niacin extended-release tablets also contain the inactive ingredients black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, lecithin, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide, and yellow iron oxide.

USP Dissolution Test 5. chemstruct

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Patient Counseling Patients should be advised to adhere to their National Cholesterol Education Program (NCEP) recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel. Patients should be advised to inform other healthcare professionals prescribing a new medication that they are taking niacin extended-release tablets. The patient should be informed of the following: Dosing Time Niacin extended-release tablets should be taken at bedtime, after a low-fat snack.

Administration on an empty stomach is not recommended. Tablet Integrity Niacin extended-release tablets should not be broken, crushed or chewed, but should be swallowed whole. Dosing Interruption If dosing is interrupted for any length of time, their physician should be contacted prior to restarting therapy; re-titration is recommended.

Muscle Pain Notify their physician of any unexplained muscle pain, tenderness, or weakness promptly. They should discuss all medication, both prescription and over the counter, with their physician. Flushing Flushing (warmth, redness, itching and/or tingling of the skin) is a common side effect of niacin therapy that may subside after several weeks of consistent niacin extended-release tablets use.

Flushing may vary in severity and is more likely to occur with initiation of therapy, or during dose increases. By dosing at bedtime, flushing will most likely occur during sleep. However, if awakened by flushing at night, the patient should get up slowly, especially if feeling dizzy, feeling faint, or taking blood pressure medications.

Advise patients of the symptoms of flushing and how they differ from the symptoms of a myocardial infarction. Use of Aspirin Medication Taking aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before dosing can minimize flushing. Diet Avoid ingestion of alcohol, hot beverages and spicy foods around the time of taking niacin extended-release tablets to minimize flushing.

Supplements Notify their physician if they are taking vitamins or other nutritional supplements containing niacin or nicotinamide. Dizziness Notify their physician if symptoms of dizziness occur. Diabetics If diabetic, to notify their physician of changes in blood glucose.

Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if niacin extended-release tablets should be discontinued [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients not to breastfeed during treatment with niacin extended-release tablets. Distributed by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 Manufactured by: Lannett Company, Inc.

Seymour, IN 47274 52074 Rev. 07/26

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Due to extensive and saturable first-pass metabolism, niacin concentrations in the general circulation are dose dependent and highly variable. Time to reach the maximum niacin plasma concentrations was about 5 hours following niacin extended-release tablets. To reduce the risk of gastrointestinal (GI) upset, administration of niacin extended-release tablets with a low-fat meal or snack is recommended.

Single-dose bioavailability studies have demonstrated that the 500 mg and 1000 mg tablet strengths are dosage form equivalent but the 500 mg and 750 mg tablet strengths are not dosage form equivalent. Metabolism The pharmacokinetic profile of niacin is complicated due to extensive first-pass metabolism that is dose-rate specific and, at the doses used to treat dyslipidemia, saturable. In humans, one pathway is through a simple conjugation step with glycine to form nicotinuric acid (NUA).

NUA is then excreted in the urine, although there may be a small amount of reversible metabolism back to niacin. The other pathway results in the formation of nicotinamide adenine dinucleotide (NAD). It is unclear whether nicotinamide is formed as a precursor to, or following the synthesis of, NAD.

Nicotinamide is further metabolized to at least N-methylnicotinamide (MNA) and nicotinamide-N-oxide (NNO). MNA is further metabolized to two other compounds, N-methyl-2-pyridone-5-carboxamide (2PY) and N-methyl-4-pyridone-5-carboxamide (4PY). The formation of 2PY appears to predominate over 4PY in humans.

At the doses used to treat hyperlipidemia, these metabolic pathways are saturable, which explains the nonlinear relationship between niacin dose and plasma concentrations following multiple-dose niacin extended-release tablets administration. Nicotinamide does not have hypolipidemic activity; the activity of the other metabolites is unknown. Elimination Following single and multiple doses, approximately 60 to 76% of the niacin dose administered as niacin extended-release tablets was recovered in urine as niacin and metabolites; up to 12% was recovered as unchanged niacin after multiple dosing.

The ratio of metabolites recovered in the urine was dependent on the dose administered. Pediatric Use No pharmacokinetic studies have been performed in this population (£16 years) [see Use in Specific Populations ( 8.4 )] . Geriatric Use No pharmacokinetic studies have been performed in this population (>65 years) [see Use in Specific Populations ( 8.5 )] .

Renal Impairment No pharmacokinetic studies have been performed in this population. Niacin extended-release tablets should be used with caution in patients with renal disease [see Warnings and Precautions ( 5 )] . Hepatic Impairment No pharmacokinetic studies have been performed in this population.

Active liver disease, unexplained transaminase elevations and significant or unexplained hepatic dysfunction are contraindications to the use of niacin extended-release tablets [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . Gender Steady-state plasma concentrations of niacin and metabolites after administration of niacin extended-release tablets are generally higher in women than in men, with the magnitude of the difference varying with dose and metabolite. This gender differences observed in plasma levels of niacin and its metabolites may be due to gender-specific differences in metabolic rate or volume of distribution.

Recovery of niacin and metabolites in urine, however, is generally similar for men and women, indicating that absorption is similar for both genders [see Gender ( 8.8 )] . Drug interactions Fluvastatin Niacin did not affect fluvastatin pharmacokinetics [see Drug Interactions ( 7.1 )] . Lovastatin When niacin extended-release tablets 2000 mg and lovastatin 40 mg were co-administered, niacin extended-release tablets increased lovastatin C max and AUC by 2% and 14%, respectively, and decreased lovastatin acid C max and AUC by 22% and 2%, respectiv… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Niacin Clinical Studies Niacin’s ability to reduce mortality and the risk of definite, nonfatal myocardial infarction (MI) has been assessed in long-term studies. The Coronary Drug Project, completed in 1975, was designed to assess the safety and efficacy of niacin and other lipid-altering drugs in men 30 to 64 years old with a history of MI. Over an observation period of 5 years, niacin treatment was associated with a statistically significant reduction in nonfatal, recurrent MI.

The incidence of definite, nonfatal MI was 8.9% for the 1119 patients randomized to nicotinic acid versus 12.2% for the 2789 patients who received placebo ( p <0.004). Total mortality was similar in the two groups at 5 years (24.4% with nicotinic acid versus 25.4% with placebo; p =N.S.). At the time of a 15-year follow-up, there were 11% (69) fewer deaths in the niacin group compared to the placebo cohort (52.0% versus 58.2%; p =0.0004).

However, mortality at 15 years was not an original endpoint of the Coronary Drug Project. In addition, patients had not received niacin for approximately 9 years, and confounding variables such as concomitant medication use and medical or surgical treatments were not controlled. The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and niacin therapy in 162 non-smoking males with previous coronary bypass surgery.

The primary, per-subject cardiac endpoint was global coronary artery change score. After 2 years, 61% of patients in the placebo cohort showed disease progression by global change score (n=82), compared with only 38.8% of drug-treated subjects (n=80), when both native arteries and grafts were considered ( p <0.005); disease regression also occurred more frequently in the drug-treated group (16.2% versus 2.4%; p =0.002). In a follow-up to this trial in a subgroup of 103 patients treated for 4 years, again, significantly fewer patients in the drug-treated group demonstrated progression than in the placebo cohort (48% versus 85%, respectively; p <0.0001).

The Familial Atherosclerosis Treatment Study (FATS) in 146 men ages 62 and younger with Apo B levels ³125 mg/dL, established coronary artery disease, and family histories of vascular disease, assessed change in severity of disease in the proximal coronary arteries by quantitative arteriography. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL-C was elevated); lovastatin plus colestipol; or niacin plus colestipol.

In the conventional therapy group, 46% of patients had disease progression (and no regression) in at least one of nine proximal coronary segments; regression was the only change in 11%. In contrast, progression (as the only change) was seen in only 25% in the niacin plus colestipol group, while regression was observed in 39%. Though not an original endpoint of the trial, clinical events (death, MI, or revascularization for worsening angina) occurred in 10 of 52 patients who received conventional therapy, compared with 2 of 48 who received niacin plus colestipol.

14.2Niacin Extended-release Tablets Clinical Studies Placebo-Controlled Clinical Studies in Patients with Primary Hyperlipidemia and Mixed Dyslipidemia: In two randomized, double-blind, parallel, multi-center, placebo-controlled trials, niacin extended-release tablets dosed at 1000, 1500 or 2000 mg daily at bedtime with a low-fat snack for 16 weeks (including 4 weeks of dose escalation) favorably altered lipid profiles compared to placebo (Table 3). Women appeared to have a greater response than men at each niacin extended-release tablets dose level (see Gender Effect , below).

Table 3. Lipid Response to Niacin Extended-release Tablets Therapy Mean Percent Change from Baseline to Week 16 Mean percent change from baseline for all niacin extended-release tablets doses was signif… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 86 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m 2 basis. Niacin was negative for mutagenicity in the Ames test.

No studies on impairment of fertility have been performed. No studies have been conducted with niacin extended-release tablets regarding carcinogenesis, mutagenesis, or impairment of fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 83 words ▾

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m 2 basis. Niacin was negative for mutagenicity in the Ames test.

No studies on impairment of fertility have been performed. No studies have been conducted with niacin extended-release tablets regarding carcinogenesis, mutagenesis, or impairment of fertility.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Niacin (nye’ a sin) Extended-release Tablets, USP for oral use Read this information carefully before you start taking niacin extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What are niacin extended-release tablets? Niacin extended-release tablets are a prescription medicine used with diet and exercise to increase the good cholesterol (HDL) and lower the bad cholesterol (LDL) and fats (triglycerides) in your blood. Niacin extended-release tablets are also used to lower the risk of heart attack in people who have had a heart attack and have high cholesterol.

In people with coronary artery disease and high cholesterol, niacin extended-release tablets, when used with a bile acid-binding resin (another cholesterol medicine) can slow down or lessen the build-up of plaque (fatty deposits) in your arteries. In people with heart problems and well-controlled cholesterol, taking niacin extended-release tablets with another cholesterol-lowering medicine (simvastatin) does not reduce heart attacks or strokes more than taking simvastatin alone. It is not known if niacin extended-release tablets are safe and effective in children 16 years of age and under.

Who should not take niacin extended-release tablets? Do not take niacin extended-release tablets if you have: liver problems. a stomach ulcer. bleeding problems. an allergy to niacin or any of the ingredients in niacin extended-release tablets. See the end of this Patient Information leaflet for a complete list of ingredients in niacin extended-release tablets.

What should I tell my doctor before taking niacin extended-release tablets? Before you take niacin extended-release tablets, tell your doctor about all your medical problems including, if you: have diabetes. Tell your doctor if your blood sugar levels change after you take niacin extended-release tablets. have gout. have kidney problems. are pregnant or plan to become pregnant.

It is not known if niacin extended-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant while taking niacin extended-release tablets. are breastfeeding or plan to breastfeed. Niacin extended-release tablets can pass into your breast milk.

You and your doctor should decide if you will take niacin extended-release tablets or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take niacin extended-release tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements or other nutritional supplements containing niacin or nicotinamide. Niacin extended-release tablets and other medicines may affect each other causing side effects. Niacin extended-release tablets may affect the way other medicines work, and other medicines may affect how niacin extended-release tablets works.

Especially tell your doctor if you take: other medicines to lower cholesterol or triglycerides aspirin blood pressure medicines blood thinner medicines large amounts of alcohol Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take niacin extended-release tablets?

Take niacin extended-release tablets exactly as your doctor tells you to take it. Take niacin extended-release tablets whole. Do not break, crush or chew niacin extended-release tablets before swallowing.

Take niacin extended-release tablets 1 time a day at bedtime after a low-fat snack. Niacin extended-release tablets should not be taken on an empty stomach. All forms of niacin are not the same as niacin extended-release tablets.

Do not switch between forms of niacin without first talking to your doctor as severe liver damage can occur. Do not change your dose or stop taking niacin extended-release tab… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 30 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70752- 295 -09 Niacin Extended-release Tablets, USP 500 mg 90 Tablets containerlabel500mg90c

NDC 70752- 296 -09 Niacin Extended-release Tablets, USP 500 mg 90 Tablets containerlabel1000mg90c

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Niacin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Niacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$110.4K
Claims incl. refills
94
Beneficiaries
65
Spend / beneficiary
$1,699.00
Spend / claim
$1,174.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by QUAGEN PHARMACEUTICALS LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
QUAGEN PHARMACEUTICALS LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70752-0295-09 · QUAGEN 70756-0001-11 · Lifestar →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.