Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Colchicine

Brand names: Colcrys, Gloperba, Lodoco

Drug class: Alkaloid

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
1Recalls (FDA reports)
29Companies
2009First FDA approval on file

Quick answers

What is Colchicine used for?
The FDA-approved label (Colcrys, Proficient Rx LP, October 1, 2022) says: “COLCRYS (colchicine, USP) tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults. • Familial Mediterranean fever (FMF) in adults and children 4 years or older. COLCRYS is not an analgesic medication and should not be used to treat pain from other causes. 1.1 Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Colchicine have a boxed warning?
No. None of the 45 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Colchicine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Colchicine been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started December 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
Who makes Colchicine?
29 companies list prescription products of Colchicine in the FDA NDC Directory, including Bryant Ranch Prepack, Direct_Rx and A-S Medication Solutions.

What Colchicine is used for

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

COLCRYS (colchicine, USP) tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults. • Familial Mediterranean fever (FMF) in adults and children 4 years or older. COLCRYS is not an analgesic medication and should not be used to treat pain from other causes. 1.1 Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares. …

— FDA label: Colcrys, Proficient Rx LP, effective October 1, 2022. Read the full label on DailyMed →

The FDA has 45 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.

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 45 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Capsule · Solution
RouteOral
Prescription products48 in the FDA NDC Directory
Brand namesColcrys, Gloperba, Lodoco

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 Colchicine, by strength and form
Strength and formGeneric or brandPharmacies pay
colchicine 0.5 mg
tablet		 Brand: Lodoco $16.99 per tablet
colchicine 0.6 mg
capsule		 Generic $1.69 per capsule
colchicine 0.6 mg
tablet		 Generic $0.1189 per tablet
colchicine 0.6 mg
tablet, film coated		 Generic $0.1189 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

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA022352
COLCRYS		 Takeda Pharms USAJuly 29, 2009 10, latest May 14, 2020
2020: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC)
NDA204820
MITIGARE		 HikmaSeptember 26, 2014 2, latest May 16, 2024
2024: Labeling · 2018: Manufacturing (CMC)
NDA210942
GLOPERBA		 Scilex PharmsJanuary 30, 2019 2, latest August 28, 2024
2024: Efficacy · 2021: Manufacturing (CMC)
NDA215727
LODOCO		 Agepha Pharma FzJune 16, 2023 —

Generic approvals (15)

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. December 18, 2024 · Class II · Terminated · D-0187-2025

    Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

    Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 — Granules Pharmaceuticals 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)197541, 858071, 1550940, 2118892, 2180558
SPL set ID of the quoted labeld6adc880-5499-4691-93f3-27c87902d5fc
FDA labels (SPL)45
FDA applicationsNDA022352, NDA204820, NDA210942, NDA215727, 15 ANDA
Active ingredients (FDA)COLCHICINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Colcrys, Proficient Rx LP, effective October 1, 2022; 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 →

Report an error → · Information for medicine makers