Niacin is a nicotinic acid sold in the U.S. under 4 brand and generic names, for hypercholesterolemia, pellagra and hypertriglyceridemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Niaspan (application NDA020381). Other niacin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ) 2.1 Initial 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 500 mg tablet at bedtime SCHEDULE 5 to 8 1000 mg 1 niacin extended-release 1000 mg tablet or 2 niacin extended-release 500 mg tablets at bedtime * 1500 mg 3 niacin extended-release 500 mg tablets at bedtime * 2000 mg 2 niacin extended-release 1000 mg tablets or 4 niacin extended-release 500 mg tablets at bedtime * After Week…
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 tablet dose). ( 2.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 to 75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $8 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 342 | 750 mg / 27 mg / 500 ug / 2 mg / 50 ug / 100 ug | white | oval | — |
| T9 | 1 mg / 100 mg / 20 mg / 1.7 mg / 10 mg / 6 ug / 5 mg / 150 ug | red | oval | — |
| PN | 780 ug / 75 mg / 15 ug / 18 mg / 3.5 mg / 21 mg / 21 mg / 400 ug / 600 ug / 160 mg / 20 mg / 13 ug / 330 ug / 150 ug / 25 mg / 15 mg / 1.5 mg | white | oval | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
GSMS Incorporated
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. · May 29, 2026
Niacin Extended-release Tablets
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc. · May 27, 2026
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Golden State Medical Supply Inc. · Oct 20, 2025
Niacin Extended-release Tablets
Failed Dissolution Specifications
Lannett Company Inc. · Oct 10, 2025
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Niacin extended-release tablet is 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 )
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 tablets administration. ( 7.2 ) 7.1 Statins 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 )]. 7.2 Bile 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 )]. 7.3 Aspirin Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear. 7.4 Antihypertensive Therapy Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. 7.5 Other Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of niacin…
| $8 |
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| 3 | Not yet rated | Prescription | Tablet | Generic | $8 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $8 | View → |