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Niacin 1000 mg Tablet, Extended Release, 90-count — NDC 65162-0323-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Niacin 1000 mg Tablet, Extended Release, 90-count — NDC 65162-323-09 (Billing 65162-0323-09)

by Amneal Pharmaceuticals LLC · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 90 tablets of Niacin 1000 mg Tablet, Extended Release from Amneal Pharmaceuticals LLC, marketed since Jul 2015 and currently FDA-listed; retail pharmacies pay about $0.3263 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 65162-0323-09
🏷️ FDA NDC (as labeled) 65162-323-09 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.3263 NADAC Per package$29.37 / 90 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4917/unit · Part D plans $0.5465/unit — full pricing hub ↓
Main listing for product 65162-323 · Also comes in: 30 tablets 65162-323-03 500 tablets 65162-323-50
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 65162-323-09 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65162 labeler · 323 product · 09 package
Package marketed since
Jul 27, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
90 EA per package
Barcode (UPC-A, from the NDC)
3 6516232309 2
Medicaid fills, this package
888 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026
⚠️
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) 65162-323-09
Product NDC 65162-323
11-digit billing NDC 65162032309
NCPDP billing unit EA — each (per item)
Application # ANDA203578
SPL Set ID 6e604319-e164-4056-ab80-b78b98c519c7
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 2015-07-27
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance NIACIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 033366
GCN 42333
HICL code 001064
Ingredient (HICL) Niacin
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4E
Therapeutic class — specific (HIC3) Lipotropics
AHFS code 24:06.92.00
AHFS class Antilipemic Agents, Miscellaneous
FDB label name NIACIN ER 1,000 MG TABLET
FDB brand name Niacin Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 033366
  • GCN: 42333
  • HICL (First Databank): 001064
  • AHFS class code: 24:06.92.00
Why two NDCs? The FDA registers this code as 65162-323-09 — 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 → 65162-0323-09. 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.

Clinical

Label name NIACIN ER 1,000 MG TABLET Ingredient Niacin
📖 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 eaPer package
Retail pharmacies payNADAC · weekly $0.326 $29.37 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.4917 $44.25 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.5465 $49.19 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.474 $0.242
▼ Down 20% over the last 24 months.
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 Per unit Per pack Marketing startMarketing endStatus
65162-0323-03 65162-323-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2015-07-27 — Active
65162-0323-09 You're viewing this Main listing 90 TABLET, EXTENDED RELEASE in 1 BOTTLE $0.3263 / ea $29.36 2015-07-27 — Active
65162-0323-50 65162-323-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2015-07-27 — Active

You're viewing one of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet, extended release in 1 bottle.
How does this package differ from NDC 65162-0323-03?
Both are Niacin 1000 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 90-count one, while NDC 65162-0323-03 is the 30 tablets package.
What NDC number is used to bill for this package of Niacin 1000 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Niacin 1000 mg 33342-0189-10 Macleods 90 tablets $0.326 AB Availability likely —
Niacin 1000 mg 62135-0498-90 Chartwell 90 tablets $0.326 AB Availability likely —
Niacin 1000 mgthis 65162-0323-09 Amneal 90 tablets $0.326 AB Availability likely —
Niacin 1000 mg 47335-0613-08 Sun 100 tablets — AB FDA listed —
Niacin 1000 mg 51407-0268-90 Golden 90 tablets — AB FDA listed —
Niacin 1000 mg 59651-0020-05 Aurobindo 500 tablets — AB FDA listed —
Niacin 1000 mg 62175-0322-43 Lannett 1000 tablets — AB FDA listed —
Niacin 1000 mg 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
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 orange
ShapeCapsule
ImprintAN;323
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.

🧪 Avoiding an ingredient? See Niacin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 ZYD53NBL45
    Hydroxyethyl cellulose is a plant-based thickening agent derived from cellulose. It helps control the texture and consistency of liquid or semi-solid medicines, and may also help keep ingredients evenly mixed throughout the product.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

8 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA203578 (ANDA)
Labeler code65162
First marketedJul 2015
Product typeHuman Prescription Drug
Portfolio490 products on file

More NDCs from Amneal Pharmaceuticals LLC labeler code 65162

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 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 2,000 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: 1,000 to 2,000 mg once daily. ( 2.2 ) Doses greater than 2,000 mg daily are not recommended. ( 2.2 )

2.1Initial Dosing Niacin extended-release tablets 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 1 to 4 500 mg 1 Niacin extended-release tablet 500 mg at bedtime SCHEDULE 5 to 8 1,000 mg 1 Niacin extended-release tablet 1,000 mg or 2 Niacin extended-release tablets 500 mg at bedtime * 1,500 mg 3 Niacin extended-release tablets 500 mg at bedtime * 2,000 mg 2 Niacin extended-release tablets 1,000 mg or 4 Niacin extended-release tablets 500 mg at bedtime * After Week 8, titrate to patient response and tolerance.

If response to 1,000 mg daily is inadequate, increase dose to 1,500 mg daily; may subsequently increase dose to 2,000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2,000 mg daily are not recommended. Women may respond at lower doses than men.

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 1,000 mg (two 500 mg tablets or one 1,000 mg tablet) to 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2,000 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 1,000 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.

2.3Dosage in Patients with Renal or Hepatic Impairment Use of niacin extended-release tablets in patients with renal or hepatic imp… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS 500 mg light orange to orange colored, round shaped, film-coated tablets debossed with ‘AN 321’ on one side and plain on the other side. 1000 mg light orange to orange colored, capsule shaped, film-coated tablets debossed with ‘AN 323’ on one side and plain on the other side. Unscored film-coated tablets for oral administration: 500 mg and 1,000 mg niacin extended-release. ( 3 )

⛔ Contraindications 91 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 preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin extended-release, therapy with niacin extended-release should be initiated with low doses (i.e. 500 mg at bedtime) and the niacin extended-release 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 is 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 is 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 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.

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 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 has 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 3,414 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 mg/dL to 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 mg/dL to 80 mg/dL, and were randomized to receive niacin extended-release 1,500 mg/day to 2,000 mg/day (n = 1,718) or matching placebo (IR Niacin, 100 mg to 150 mg, n = 1,696). On-treatment lipid changes at two years for LDL-C were -12.0% for the simvastatin plus niacin extended-release 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 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 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 primary outcome occurred in 282 patients in the simvastatin plus niacin extende… [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 dose). ( 2.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 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 years to 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 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 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 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. 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 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. Following 4 weeks of maintenance therapy at daily doses of 1,500 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.

Other adverse reactions occurring in ≥ 5% of patients treated with niacin extended-release 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 Treatment @ Recommended Daily Maintenance Doses † Placebo (n = 157) 500 mg ‡ (n = 87) 1,000 mg (n = 110) 1,500 mg (n = 136) 2,000 mg (n = 95) % % % % % Gastrointestinal Disorders Diarrhea 13 7 10 10 14 Nausea 7 5 6 4 11 Vomiting 4 0 2 4 9 Respiratory Cough, Increased 6 3 2 < 2 8 Skin and Subcutaneous Tissue Disorders Pruritus 2 8 0 3 0 Rash 0 5 5 5 0 Vascular Disorders Flushing & 19 68 69 63 55 Note: Percentages are calculated from the total number of patients in each column. † Adverse reactions are reported at the ini… [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 [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 ~2 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 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 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 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% to 4% and 15% to 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.

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, 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 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 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 [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.

🆘 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. To reduce the risk of gastrointestinal (GI) upset, administration of niacin extended-release with a low-fat meal or snack is recommended.

Single-dose bioavailability studies have demonstrated that the 500 mg and 1,000 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 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 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 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 [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, in… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Niacin extended-release tablets USP, 500 mg are supplied as light orange to orange colored, round shaped, film-coated tablets debossed with “AN 321” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-321-03 Bottles of 90: NDC 65162-321-09 Bottles of 500: NDC 65162-321-50 Niacin extended-release tablets USP, 1000 mg are supplied as light orange to orange colored, capsule shaped, film-coated tablets debossed with “AN 323” on one side and plain on the other side.

They are available as follows: Bottles of 30: NDC 65162-323-03 Bottles of 90: NDC 65162-323-09 Bottles of 500: NDC 65162-323-50 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 110 words ▾

11 DESCRIPTION Niacin extended-release tablets, USP contain niacin, USP 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, USP are unscored, light orange to orange, film-coated tablets for oral administration and are available in two tablet strengths containing 500 mg and 1,000 mg niacin, USP. Niacin extended-release tablets, USP also contain the following inactive ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, hydroxyethyl cellulose, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 400, stearic acid and titanium dioxide.

FDA approved dissolution test specifications differ from USP. 4097803e-figure-01

💬 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. 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 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 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 should be discontinued [see Use in Specific Populations (8.1) ] . Lactation Advise patients not to breastfeed during treatment with niacin extended-release tablet. Manufactured By: Amneal Pharmaceuticals Pvt.

Ltd. Ahmedabad 382220, INDIA Distributed By: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2025-06

🔬 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 1,119 patients randomized to nicotinic acid versus 12.2% for the 2,789 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 ≥125 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 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 dosed at 1,000 mg, 1,500 mg or 2,000 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 dose level (see Gender Effect , below).

Table 3. Lipid Response to Niacin Extended-Release Therapy Mean Percent Change from Baseline to Week 16 * Treatment n TC LDL-C HDL-C TG Apo B Niacin Extended-Release 1,000 mg at 41 -3 -5 +18 -21 -6 bedtime Niaci… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 85 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 3,000 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 regarding carcinogenesis, mutagenesis, or impairment of fertility.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Niacin (nye’ a sin) Extended-Release Tablets for oral use Read this information carefully before you start taking niacin extended-release tablet(s) 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 tablet(s)? Niacin extended-release tablet(s) 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 tablet(s) is 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 tablet(s), 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 tablet(s) 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 tablet(s) is safe and effective in children 16 years of age and under.

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

What should I tell my doctor before taking niacin extended-release tablet(s)? Before you take niacin extended-release tablet(s), 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 tablet(s). have gout. have kidney problems. are pregnant or plan to become pregnant.

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

You and your doctor should decide if you will take niacin extended-release tablet(s) 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 tablet(s).

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 tablet(s) and other medicines may affect each other causing side effects. Niacin extended-release tablet(s) may affect the way other medicines work, and other medicines may affect how niacin extended-release tablet(s) 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 tablet(s)?

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

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

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 nia… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 32 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65162-321-03 Niacin Extended-release Tablets, 500 mg 30 Tablets Amneal Pharmaceuticals LLC 500 mg

NDC 65162-323-03 Niacin Extended-release Tablets, 1000 mg 30 Tablets Amneal Pharmaceuticals LLC 1000 mg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
888
Units reimbursed last 4 qtrs
44K
Gross reimbursed last 4 qtrs
$21.6K
Avg / prescription
$24.34
Avg / unit
$0.4917
Latest quarter Q1 2026
164Rx
Medicaid pays / ea
$0.4917
gross reimbursed
vs
NADAC / ea
$0.3263
acquisition cost
=
Spread
+$0.1654
+51% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
74% FFS 26% MCO
Fee-for-service · 653 Rx Managed care · 235 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 594 units · 7.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 552 units · 9.6 per 100k residents MN Wisconsin: 3,156 units · 53.4 per 100k residents WI Michigan: no data reported MI New York: 21,770 units · 111 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 377 units · 3.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 3,970 units · 42.7 per 100k residents NJ Massachusetts: no data reported MA California: 4,650 units · 11.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 3,238 units · 52.3 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,980 units · 22.7 per 100k residents VA Maryland: 926 units · 15.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 776 units · 7.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 930 units · 20.3 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,036 units · 9.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.2111
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 111 /100k
2 Wisconsin 53.4 /100k
3 Missouri 52.3 /100k
4 New Jersey 42.7 /100k
5 Virginia 22.7 /100k
6 Louisiana 20.3 /100k
7 Maryland 15.0 /100k
8 California 11.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 tablets this page65162-0323-09 888 Rx · $21,611
30 tablets65162-0323-03 No Medicaid data
500 tablets65162-0323-50 No Medicaid data
Drug total (last 4 qtrs): 888 Rx · 43,955 units · $21,611 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 65162-0322-03 · Amneal 65162-0339-63 · Amneal →
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.