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Prescription medicine · generic available

Niacin

Brand names: Niacor

Drug class: Nicotinic Acid

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
6Recalls (FDA reports)
13Companies
2000First FDA approval on file

Quick answers

What is Niacin used for?
The FDA-approved label (Niacor, Avondale Pharmaceuticals, LLC, December 23, 2021) says: “I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Niacin have a boxed warning?
No. None of the 13 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Niacin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Niacin been recalled?
FDA enforcement reports list 6 recalls of products of this medicine; the newest started May 29, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Niacin?
13 companies list prescription products of Niacin in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, Sun Pharmaceutical Industries, Inc. and Aurobindo Pharma Limited.

What Niacin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. …

— FDA label: Niacor, Avondale Pharmaceuticals, LLC, effective December 23, 2021. Read the full label on DailyMed →

The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Diabetes

Related medical specialties

Endocrinology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 13 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, extended release · Tablet · Tablet, film coated, extended release
RouteOral
Prescription products24 in the FDA NDC Directory
Brand namesNiacor

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Niacin, by strength and form
Strength and formGeneric or brandPharmacies pay
niacin 1000 mg
tablet		 Generic $0.3240 per tablet
niacin 1000 mg
tablet, extended release		 Generic $0.3240 per tablet
niacin 1000 mg
tablet, film coated, extended release		 Generic $0.3240 per tablet
niacin 500 mg
tablet		 Generic $0.1935 per tablet
niacin 500 mg
tablet, extended release		 Generic $0.1935 per tablet
niacin 500 mg
tablet, film coated, extended release		 Generic $0.1935 per tablet
niacin 750 mg
tablet, extended release		 Generic $0.2695 per tablet
niacin 750 mg
tablet, film coated, extended release		 Generic $0.2695 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (9)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. May 29, 2026 · Class II · Ongoing · D-0587-2026

    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.

    GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, — Golden State Medical Supply Inc.

  2. May 27, 2026 · Class II · Ongoing · D-0584-2026

    Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

    Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Lannett Company Inc.

  3. October 20, 2025 · Class II · Ongoing · D-0158-2026

    Failed Dissolution Specifications

    NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporat — Golden State Medical Supply Inc.

  4. October 10, 2025 · Class II · Ongoing · D-0096-2026

    Failed Dissolution Specifications

    Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 — Lannett Company Inc.

  5. January 18, 2024 · Class II · Completed · D-0270-2024

    CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/ — SUN PHARMACEUTICAL INDUSTRIES INC

  6. January 18, 2024 · Class II · Completed · D-0269-2024

    CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259 — SUN PHARMACEUTICAL INDUSTRIES INC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)198024, 311944, 1098134, 1098141, 1098143
SPL set ID of the quoted labelbf287412-160b-403f-8eb4-57f29a475902
FDA labels (SPL)13
FDA applications9 ANDA
Active ingredients (FDA)NIACIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Niacor, Avondale Pharmaceuticals, LLC, effective December 23, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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