Prescription medicine
Niacin Brand names: Niacor; first approved as Wampocap
Niacin (Niacor) is a prescription medicine with an FDA approval on record since 1957. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.193 per niacin ER 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the niacin FDA label on DailyMed (effective February 14, 2023, Aurobindo Pharma Limited); the NDA 11073 record on Drugs@FDA; every niacin label on DailyMed.
Highlights of the record
FDA label of February 14, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTherapy 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.
Forms and strengths
- 500 mg
- 750 mg
- 1000 mg
Extended-release tablet; tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- July 24, 1957 Wampocap, Medpointe Pharm Hlc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first September 15, 1972; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 13 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.193 per tablet Niacin ER 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest May 29, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 11,548 through July 30, 2026
What is niacin used for?
From the label: indications and usageTherapy 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. […]
Conditions named in the indications of niacin's FDA labels, with every medicine labeled for each:
From other niacin labelsHeart attack and coronary artery disease: In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
High triglycerides: 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.
FDA pharmacologic class: Nicotinic Acid.
Source: FDA drug label (Niacin), Aurobindo Pharma Limited, effective February 14, 2023 (SPL set 43233a21-3f90-4c69-bbeb-f50d5f2d35ae), via openFDA; the full label on DailyMed
Is there a generic for niacin (Niacor)?
The FDA approved the first generic niacin on September 15, 1972. 27 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists niacin from 13 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1957 earliest approval on file
- 1972 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for niacin (Niacor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.193 per Niacin ER 500 mg tablet, up 17% from $0.165 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Niacin ER 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Niacin ER 1,000 mg tablet | Generic | $0.326 per tablet | $9.79 | +9% |
| Niacin ER 500 mg tablet | Generic | $0.193 per tablet | $5.79 | +17% |
| Niacin ER 750 mg tablet | Generic | $0.285 per tablet | $8.54 | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has niacin been recalled?
The FDA's Enforcement Report lists 11 recalls naming niacin since 2013: 0 Class I (the most serious), 11 Class II, 0 Class III; 4 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of niacin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 29, 2026 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the … |
| May 27, 2026 | Class II | Lannett Company Inc. | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. |
| October 20, 2025 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications |
| October 10, 2025 | Class II | Lannett Company Inc. | Failed Dissolution Specifications |
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| November 26, 2013 | Class II | Teva Pharmaceuticals USA | Failed Tablet/Capsule Specifications: There is a potential for broken tablets. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the niacin label say about other medicines?
The niacin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name niacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. |
| Ezetimibe | warnings and precautions | 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 to 80 mg/dL, and were randomized to receive niacin extended-release tablets 1,500 to 2,000 mg/day (n=1718) or matching placebo (IR Niacin, 100 to 150 mg, n=1696). |
| Simvastatin | warnings and precautions | 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 to 80 mg/dL, and were randomized to receive niacin extended-release tablets 1,500 to 2,000 mg/day (n=1718) or matching placebo (IR Niacin, 100 to 150 mg, n=1696). |
Other labels that name niacin
Source: FDA drug label (Niacin), Aurobindo Pharma Limited, effective February 14, 2023 (SPL set 43233a21-3f90-4c69-bbeb-f50d5f2d35ae), via openFDA; the full label on DailyMed
What do FAERS reports show for niacin?
The FDA Adverse Event Reporting System holds 11,548 reports that list niacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 757 are coded as a death and 3,226 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as niacin?
19 other medicines are given the same way (oral) and in the same FDA class as niacin or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Fenofibrate | High cholesterol, High triglycerides | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Gemfibrozil | Heart attack and coronary artery disease, High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does niacin compare with medicines for the same use?
3 side-by-side pages set niacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to niacin
- 19 medicines for the same use
- Niacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other