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Colchicine .6 mg Tablet, Film Coated, 3-count — NDC 72189-0249-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Colchicine .6 mg Tablet, Film Coated, 3-count — NDC 72189-249-03 (Billing 72189-0249-03)

by direct rx · 3 TABLET, FILM COATED in 1 BOTTLE

This is a package of 3 tablets of Colchicine .6 mg Tablet, Film Coated from direct rx, marketed since Jul 2021 and currently FDA-listed. It is this product's only package size.

NDC 72189-0249-03
🏷️ FDA NDC (as labeled) 72189-249-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-249-03
Product NDC 72189-249
11-digit billing NDC 72189024903
NCPDP billing unit EA — each (per item)
RxCUI 197541
UNII SML2Y3J35T
Application # NDA022352
SPL Set ID c7d013b7-0a67-0953-e053-2a95a90ac47c
Established class (EPC) Alkaloid
Chemical class Alkaloids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance COLCHICINE

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

GPI-14 68000020000310
GPI class Colchicine
GCN Seq No 008334
GCN 35674
HICL code 003717
Ingredient (HICL) Colchicine
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2A
Therapeutic class — specific (HIC3) Colchicine
AHFS code 24:44.00.00
AHFS class Cardiovascular Drugs, Nsaid Anti-Infl
FDB label name COLCHICINE 0.6 MG TABLET
FDB brand name Colchicine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008334
  • GCN: 35674
  • GPI-14 (Medi-Span): 68000020000310
  • HICL (First Databank): 003717
  • AHFS class code: 24:44.00.00
  • RxCUI (RxNorm): 197541
Why two NDCs? The FDA registers this code as 72189-249-03 — 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 → 72189-0249-03. 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.

RxNorm drug class

This medicine belongs to the Alkaloid class.

Pharmacologic class Alkaloid
Drug family (ATC) Preparations with no effect on uric acid metabolism
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name COLCHICINE 0.6 MG TABLET Ingredient Colchicine
📖 What it is MedlinePlus · NLM

Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults. Colchicine is also used to relieve the pain of gout attacks when they occur. Colchicine is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine (Lodoco®) is used to reduce the risk of heart attack, stroke, cardiovascular death, and needing certain ty...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Most colchicine products — tablets, capsules, and the liquid Gloperba — are used to prevent gout flares in adults. Colcrys tablets and generic colchicine...
  • Diarrhea is the most common side effect and it's a real nuisance for many people. Colchicine affects the lining of the gut, and nausea, cramping, and loose stools often come with i...
  • Why does colchicine cause so much diarrhea?
  • This is one of the most important questions you can ask. Colchicine has some serious drug interactions that have caused deaths — not just discomfort. Certain antibiotics (like clar...
📖 Read our full Colchicine guide →
2
Nutrient depletion considerations

Colchicine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Colchicine 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3755 $1.13 / 3 tablets
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 Marketing startMarketing endStatus
72189-0249-03 You're viewing this Main listing 3 TABLET, FILM COATED in 1 BOTTLE 2021-07-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colchicine .6 mg 00904-7120-04 Major 1 tablet $0.122 AB Availability likely —
Colchicine .6 mg 16714-0039-01 Northstar 30 tablets $0.122 — Availability likely —
Colchicine .6 mg 23155-0855-01 Heritage 100 tablets $0.122 AB Discontinued —
Colchicine .6 mg 31722-0899-01 Camber 100 tablets $0.122 AB Availability likely —
colchicine .6 mg 43598-0372-01 Dr.Reddys 100 tablets $0.122 AB Availability likely —
Colchicine .6 mg 49884-0171-01 Par 100 tablets $0.122 AB Availability likely —
Colchicine .6 mg 50268-0187-15 AvPAK 50 tablets $0.122 AB Availability likely —
Colchicine .6 mg 59651-0455-01 Aurobindo 100 tablets $0.122 AB Availability likely —
Colchicine .6 mg 60687-0727-21 American 1 tablet $0.122 AB Availability likely —
Colchicine .6 mg 62135-0789-30 Chartwell 30 tablets $0.122 AB Availability likely —
Colchicine .6 mg 65162-0710-03 Amneal 30 tablets $0.122 AB Availability likely —
colchicine .6 mg 67877-0589-01 Ascend 100 tablets $0.122 AB Availability likely —
Colchicine .6 mg 70010-0002-01 Granules 100 tablets $0.122 AB Availability likely —
Colchicine .6 mg 70710-1351-01 Zydus 100 tablets $0.122 — Availability likely —
Colchicine .6 mg 64380-0796-04 Strides 30 tablets $0.134 AB Discontinued —
Colchicine .6 mg 00378-1086-01 Mylan 100 tablets $0.287 AB FDA listed —
Colchicine .6 mg 33342-0341-07 Macleods 30 tablets — AB FDA listed —
Colchicine .6 mg 50090-7205-07 A-S 4 tablets — — FDA listed —
Colchicine .6 mg 51407-0082-01 Golden 100 tablets — AB FDA listed —
colchicine .6 mg 60760-0839-10 ST. 10 tablets — AB FDA listed —
Colcrys .6 mg 63187-0292-03 Proficient 3 tablets — — FDA listed —
Colchicine .6 mg 63629-2166-01 Bryant 100 tablets — — FDA listed —
Colchicine .6 mg 63629-2167-01 Bryant 30 tablets — — FDA listed —
colchicine .6 mg 63629-8362-01 Bryant 30 tablets — AB FDA listed —
colchicine .6 mg 63629-8766-01 Bryant 100 tablets — AB FDA listed —
colchicine .6 mg 68071-2567-09 NuCare 90 tablets — AB FDA listed —
Colchicine .6 mg 70518-3851-00 REMEDYREPACK 9 tablets — AB Discontinued —
colchicine .6 mg 70518-4000-01 REMEDYREPACK 9 tablets — AB FDA listed —
colchicine .6 mg 71205-0687-10 Proficient 10 tablets — AB FDA listed —
colchicine .6 mg 71335-1738-01 Bryant 30 tablets — AB FDA listed —
Colchicine .6 mg 71335-1802-01 Bryant 30 tablets — — FDA listed —
Colchicine .6 mg 71335-2791-01 Bryant 30 tablets — AB FDA listed —
Colchicine .6 mg 71610-0494-03 Aphena 9 tablets — AB FDA listed —
colchicine .6 mg 72162-1855-01 Bryant 100 tablets — AB FDA listed —
Colchicine .6 mgthis 72189-0249-03 direct 3 tablets — — FDA listed —
Colchicine .6 mg 72189-0331-03 Direct 3 tablets — AB FDA listed —
Colchicine .6 mg 72789-0572-30 PD-Rx 30 tablets — AB FDA listed —
colchicine .6 mg 50090-8014-07 A-S 4 tablets — AB FDA listed —
Colchicine .6 mg 72189-0687-03 Direct_Rx 3 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2009
First FDA approval
Jul 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 29, 2009 RLD RS ⏳ ~2.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7619004 — method of use (U-1020)
US 7820681 — method of use (U-1020)
US 7915269 — method of use (U-1007)
US 7964647 — method of use (U-1007)
US 8093297 — method of use (U-1161)
US 8097655 — method of use (U-1020)
US 8415396 — method of use (U-1007)
US 8440722 — method of use (U-1020)
US 7601758 — method of use (U-1007)
US 7906519 — method of use (U-1116)
US 7935731 — method of use (U-1116)
US 8093296 — method of use (U-1007)
US 8093298 — method of use (U-1116)
US 8415395 — method of use (U-1007)
US 8440721 — method of use (U-1007)
US 7981938 — method of use (U-1166)
US 7964648 — method of use (U-1161)
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (17)
PatentTypeUse codeExpires
US 7619004 ↗ Method of use U-1020 Dec 3, 2028
US 7820681 ↗ Method of use U-1020 Feb 17, 2029
US 7915269 ↗ Method of use U-1007 Feb 17, 2029
US 7964647 ↗ Method of use U-1007 Oct 6, 2028
US 8093297 ↗ Method of use U-1161 Oct 6, 2028
US 8097655 ↗ Method of use U-1020 Oct 6, 2028
US 8415396 ↗ Method of use U-1007 Oct 6, 2028
US 8440722 ↗ Method of use U-1020 Feb 17, 2029
US 7601758 ↗ Method of use U-1007 Feb 10, 2029
US 7906519 ↗ Method of use U-1116 Feb 17, 2029
US 7935731 ↗ Method of use U-1116 Dec 3, 2028
US 8093296 ↗ Method of use U-1007 Oct 6, 2028
US 8093298 ↗ Method of use U-1116 Oct 6, 2028
US 8415395 ↗ Method of use U-1007 Oct 6, 2028
US 8440721 ↗ Method of use U-1007 Feb 17, 2029
US 7981938 ↗ Method of use U-1166 Oct 6, 2028
US 7964648 ↗ Method of use U-1161 Oct 6, 2028
Common questions
Is there a generic version of COLCHICINE 0.6 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for COLCHICINE 0.6 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 purple
ShapeOval
ImprintAR;374
Size8 mm
ScoringScored — splits in 2
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.

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

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

13 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

Labelerdirect rx
Application holderTAKEDA PHARMACEUTICALS USA INC
FDA applicationNDA022352 (NDA)
Labeler code72189
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio204 products on file
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 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 80 words ▾

1.1Gout Flares Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. Prophylaxis of Gout Flares: Colchicine Tablets, USP are indicated for prophylaxis of gout flares. Treatment of Gout Flares: Colchicine Tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare.

1.2Familial Mediterranean Fever (FMF) Colchicine Tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

⏱️ Dosage and Administration ~3 min read ▾

The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for Colchicine Tablets, USP are different for each indication and must be individualized. The recommended dosage of Colchicine Tablets, USP depends on the patient's age, renal function, hepatic function and use of coadministered drugs [see DOSAGE AND ADMINISTRATION (2.4, 2.5, 2.6)].

Colchicine Tablets, USP are administered orally without regard to meals. Colchicine Tablets, USP are not an analgesic medication and should not be used to treat pain from other causes.

2.1Gout Flares Prophylaxis of Gout Flares The recommended dosage of Colchicine Tablets, USP for prophylaxis of gout flares for adults and adolescents older than 16 years of age is 0.6 mg once or twice daily. The maximum recommended dose for prophylaxis of gout flares is 1.2 mg/day. An increase in gout flares may occur after initiation of uric acid-lowering therapy, including pegloticase, febuxostat and allopurinol, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.

Colchicine Tablets, USP are recommended upon initiation of gout flare prophylaxis with uric acid-lowering therapy. Prophylactic therapy may be beneficial for at least the first six months of uric acid-lowering therapy. Treatment of Gout Flares The recommended dose of Colchicine Tablets, USP for treatment of a gout flare is 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.

Higher doses have not been found to be more effective. The maximum recommended dose for treatment of gout flares is 1.8 mg over a 1 hour period. Colchicine Tablets, USP may be administered for treatment of a gout flare during prophylaxis at doses not to exceed 1.2 mg (two tablets) at the first sign of the flare followed by 0.6 mg (one tablet) one hour later.

Wait 12 hours and then resume the prophylactic dose.

2.2FMF The recommended dosage of Colchicine Tablets, USP for FMF in adults is 1.2 to 2.4 mg daily. Colchicine Tablets, USP should be increased as needed to control disease and as tolerated in increments of 0.3 mg/day to a maximum recommended daily dose. If intolerable side effects develop, the dose should be decreased in increments of 0.3 mg/day. The total daily Colchicine Tablets, USP dose may be administered in one to two divided doses.

2.3Recommended Pediatric Dosage Prophylaxis and Treatment of Gout Flares Colchicine Tablets, USP are not recommended for pediatric use in prophylaxis or treatment of gout flares. FMF The recommended dosage of Colchicine Tablets, USP for FMF in pediatric patients four years of age and older is based on age. The following daily doses may be given as a single or divided dose twice daily: Children 4 to 6 years: 0.3 mg to 1.8 mg daily Children 6 to 12 years: 0.9 mg to 1.8 mg daily Adolescents older than 12 years: 1.2 mg to 2.4 mg daily

2.4Dose Modification for Coadministration of Interacting Drugs Concomitant Therapy Coadministration of Colchicine Tablets, USP with drugs known to inhibit CYP3A4 and/or P-glycoprotein (P-gp) increases the risk of colchicine-induced toxic effects (Table 1). If patients are taking or have recently completed treatment with drugs listed in Table 1 within the prior 14 days, the dose adjustments are as shown in the table below [see DRUG INTERACTIONS (7)]. Table 1.

Colchicine Tablets, USP Dose Adjustment for Coadministration with Interacting Drugs if No Alternative Available* * For magnitude of effect on colchicine plasma concentrations [see CLINICAL PHARMACOLOGY (12.3)] † Patients with renal or hepatic impairment should not be given Colchicine Tablets, USP in conjunction with strong CYP3A4 or P-gp inhibitors [see CONTRAINDICATIONS (4)] ‡ When used in combination with Ritonavir, see dosing recommendations for strong CYP3A4 inhibitors [see CONTRAINDICATIONS (4)] Strong CYP3A4 Inhibitors†… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 21 words ▾

Tablets: 0.6 mg colchicine — purple capsule-shaped, film-coated with "AR 374" debossed on one side and scored on the other side.

⛔ Contraindications 45 words ▾

Patients with renal or hepatic impairment should not be given Colchicine Tablets, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses.

⚠️ Warnings and Cautions ~1 min read ▾

5.1Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see OVERDOSAGE (10)]. Colchicine Tablets, USP should be kept out of the reach of children.

5.2Blood Dyscrasias Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia have been reported with colchicine used in therapeutic doses.

5.3Drug Interactions Colchicine is a P-gp and CYP3A4 substrate. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine given with P-gp and strong CYP3A4 inhibitors. If treatment with a P-gp or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, the patient's dose of colchicine may need to be reduced or interrupted [see DRUG INTERACTIONS (7)].

Use of Colchicine Tablets, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir) is contraindicated in patients with renal or hepatic impairment [see CONTRAINDICATIONS (4)].

5.4Neuromuscular Toxicity Colchicine-induced neuromuscular toxicity and rhabdomyolysis have been reported with chronic treatment in therapeutic doses. Patients with renal dysfunction and elderly patients, even those with normal renal and hepatic function, are at increased risk. Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate (themselves associated with myotoxicity) or cyclosporine with Colchicine Tablets, USP may potentiate the development of myopathy [see DRUG INTERACTIONS (7)].

Once colchicine is stopped, the symptoms generally resolve within one week to several months.

🤒 Adverse Reactions ~3 min read ▾

Prophylaxis of Gout Flares The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. Treatment of Gout Flares The most common adverse reactions reported in the clinical trial with Colchicine Tablets, USP for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating Colchicine Tablets, USP, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses.

Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting. These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity.

6.1Clinical Trials Experience in Gout Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. In a randomized, double-blind, placebo-controlled trial in patients with a gout flare, gastrointestinal adverse reactions occurred in 26% of patients using the recommended dose (1.8 mg over one hour) of Colchicine Tablets, USP compared to 77% of patients taking a nonrecommended high-dose (4.8 mg over six hours) of colchicine and 20% of patients taking placebo.

Diarrhea was the most commonly reported drug-related gastrointestinal adverse event. As shown in Table 3, diarrhea is associated with Colchicine Tablets, USP treatment. Diarrhea was more likely to occur in patients taking the high-dose regimen than the low-dose regimen.

Severe diarrhea occurred in 19% and vomiting occurred in 17% of patients taking the nonrecommended high-dose colchicine regimen but did not occur in the recommended low-dose Colchicine Tablets, USP regimen. Table 3. Number (%) of Patients with at Least One Drug-Related Treatment-Emergent Adverse Event with an Incidence of ≥2% of Patients in Any Treatment Group MedDRA System Organ Class MedDRA Preferred Term Colchicine Tablets, USP Dose Placebo (N=59) n (%) High (N=52) n (%) Low (N=74) n (%) Number of Patients with at Least One Drug-Related TEAE 40 (77) 27 (37) 16 (27) Gastrointestinal Disorders 40 (77) 19 (26) 12 (20) Diarrhea 40 (77) 17 (23) 8 (14) Nausea 9 (17) 3 (4) 3 (5) Vomiting 9 (17) 0 0 Abdominal Discomfort 0 0 2 (3) General Disorders and Administration Site Conditions 4 (8) 1 (1) 1 (2) Fatigue 2 (4) 1 (1) 1 (2) Metabolic and Nutrition Disorders 0 3 (4) 2 (3) Gout 0 3 (4) 1 (2) Nervous System Disorders 1 (2) 1 (1.4) 2 (3) Headache 1 (2) 1 (1) 2 (3) Respiratory Thoracic Mediastinal Disorders 1 (2) 2 (3) 0 Pharyngolaryngeal Pain 1 (2) 2 (3) 0

6.2Postmarketing Experience Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems. These most often occur with excessive accumulation or overdosage [see OVERDOSAGE (10)]. The following adverse reactions have been identified with colchicine.

These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Neurological: sensory motor neuropathy Dermatological: alopecia, maculopapular rash, purpura, rash Digestive: abdominal cramping, abdominal pain, diarrhea, lactose intolerance, nausea, vomiting Hematological: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia Hepatobiliary: elevated AST, elevated ALT Musculoskeletal: myopathy, elevated CPK, myotonia, muscle weakness, muscle pain, rhabdomyolysis Reproductive: azoospermia, oligospermia

🔄 Drug Interactions ~1 min read ▾

Colchicine is a substrate of the efflux transporter P-glycoprotein (P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly involved in the metabolism of colchicine. If Colchicine Tablets, USP are administered with drugs that inhibit P-gp, most of which also inhibit CYP3A4, increased concentrations of colchicine are likely.

Fatal drug interactions have been reported. Physicians should ensure that patients are suitable candidates for treatment with Colchicine Tablets, USP and remain alert for signs and symptoms of toxicities related to increased colchicine exposure as a result of a drug interaction. Signs and symptoms of colchicine toxicity should be evaluated promptly and, if toxicity is suspected, Colchicine Tablets, USP should be discontinued immediately.

Table 4 provides recommendations as a result of other potentially significant drug interactions. Table 1 provides recommendations for strong and moderate CYP3A4 inhibitors and P-gp inhibitors. Table 4.

Other Potentially Significant Drug Interactions Concomitant Drug Class or Food Noted or Anticipated Outcome Clinical Comment HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long-term regimen of the other has resulted in myopathy and rhabdomyolysis (including a fatality) Weigh the potential benefits and risks and carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during initial therapy; monitoring CPK (creatine phosphokinase) will not necessarily prevent the occurrence of severe myopathy.

Other Lipid-Lowering Drugs: fibrates, gemfibrozil Digitalis Glycosides: digoxin P-gp substrate; rhabdomyolysis has been reported

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see DATA). Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with Colchicine Tablets, USP, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US 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.

Data Human Data Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, Behcet's disease, or familial Mediterranean fever (FMF) treated with colchicine at therapeutic doses during pregnancy. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.

8.2Lactation Risk Summary Colchicine is present in human milk (see DATA). Adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. There are no data on the effects of colchicine on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Colchicine Tablets, USP and any potential adverse effects on the breastfed child from Colchicine Tablets, USP or from the underlying maternal condition. Data Limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. A systematic review of literature reported no adverse effects in 149 breastfed children.

In a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants.

8.3Females and Males of Reproductive Potential Infertility Case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. A case report indicated that azoospermia was reversed when therapy was stopped. Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility.

However, since the progression of FMF without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see NONCLINICAL TOXICOLOGY (13.1)].

8.4Pediatric Use The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies. There does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine. Safety and effectiveness of colchicine in pediatric patients with gout has not been established.

8.5Geriatric Use Clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of FMF did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see DOSAGE AND ADMINISTRATION (2.4), CLINICAL PHARMACOLOGY (12.3)].

8.6Renal Impairment… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~1 min read ▾

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a four day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions such as myelosuppression.

There was 100% mortality in those who ingested more than 0.8 mg/kg. The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen.

Life-threatening complications occur during the second stage, which occurs 24 to 72 hours after drug administration, attributed to multiorgan failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery of multiorgan injury may be accompanied by rebound leukocytosis and alopecia starting about one week after the initial ingestion.

Treatment of colchicine poisoning should begin with gastric lavage and measures to prevent shock. Otherwise, treatment is symptomatic and supportive. No specific antidote is known.

Colchicine is not effectively removed by dialysis [see CLINICAL PHARMACOLOGY (12.3)].

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action The mechanism by which Colchicine Tablets, USP exert their beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules, and consequently prevents the activation, degranulation and migration of neutrophils thought to mediate some gout symptoms.

12.3Pharmacokinetics Absorption In healthy adults, colchicine is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in one to two hours (range 0.5 to 3 hours) after a single dose administered under fasting conditions. Following oral administration of Colchicine Tablets, USP given as 1.8 mg colchicine over one hour to healthy, young adults under fasting conditions, colchicine appears to be readily absorbed, reaching mean maximum plasma concentrations of 6.2 ng/mL at a median 1.81 hours (range: 1.0 to 2.5 hours).

Following administration of the nonrecommended high-dose regimen (4.8 mg over six hours), mean maximal plasma concentrations were 6.8 ng/mL, at a median 4.47 hours (range: 3.1 to 7.5 hours). After ten days on a regimen of 0.6 mg twice daily, peak concentrations are 3.1 to 3.6 ng/mL (range 1.6 to 6.0 ng/mL), occurring 1.3 to 1.4 hours postdose (range 0.5 to 3.0 hours). Mean pharmacokinetic parameter values in healthy adults are shown in Table 5.

Table 5. Mean (%CV) Pharmacokinetic Parameters in Healthy Adults Given Colchicine Tablets, USP Cmax (Colchicine ng/mL) Tmax* (h) Vd/F (L) CL/F (L/hr) t1/2 (h) CL = Dose/AUC0-t (calculated from mean values) Vd = CL/Ke (calculated from mean values) * Tmax mean (range) Colchicine Tablets, USP 0.6 mg Single Dose (N=13) 2.5 (28.7) 1.5 (1.0 – 3.0) 341.5 (54.4) 54.1 (31.0) -- Colchicine Tablets, USP 0.6 mg Twice Daily × 10 Days (N=13) 3.6 (23.7) 1.3 (0.5 – 3.0) 1150 (18.7) 30.3 (19.0) 26.6 (16.3) In some subjects, secondary colchicine peaks are seen, occurring between three and 36 hours postdose and ranging from 39 to 155% of the height of the initial peak.

These observations are attributed to intestinal secretion and reabsorption and/or biliary recirculation. Absolute bioavailability is reported to be approximately 45%. Administration of Colchicine Tablets, USP with food has no effect on the rate of colchicine absorption but does decrease the extent of colchicine by approximately 15%.

This is without clinical significance. Distribution The mean apparent volume of distribution in healthy young volunteers is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low, 39 ± 5%, primarily to albumin regardless of concentration.

Colchicine crosses the placenta (plasma levels in the fetus are reported to be approximately 15% of the maternal concentration). Colchicine also distributes into breast milk at concentrations similar to those found in the maternal serum [see USE IN SPECIFIC POPULATIONS (8.1, 8.2)]. Metabolism Colchicine is demethylated to two primary metabolites, 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively) and one minor metabolite, 10-O-demethylcolchicine (also known as colchiceine).

In vitro studies using human liver microsomes have shown that CYP3A4 is involved in the metabolism of colchicine to 2- and 3-DMC. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Elimination/Excretion In healthy volunteers (n=12), 40 to 65% of 1 mg orally administered colchicine was recovered unchanged in urine.

Enterohepatic recirculation and biliary excretion are also postulated to play a role in colchicine elimination. Following multiple oral doses (0.6 mg twice daily), the mean elimination half-lives in young healthy volunteers (mean age 25 to 28 years of age) is 26.6 to 31.2 hours. Colchicine is a subs… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 49 words ▾

16.1How Supplied Colchicine Tablets, USP 0.6 mg are purple, film-coated, capsule-shaped tablets debossed with "AR 374" on one side and scored on the other side.

16.2Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

📋 Description 114 words ▾

Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. [Chemical Structure] Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine Tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575" × 0.3030"), debossed with "AR 374" on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP.

Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Colchicine Tablets, USP for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration OS2008-01-75-02 COL345 R2 Revised: July 2020 Read the Medication Guide that comes with Colchicine Tablets, USP before you start taking it and each time you get a refill. There may be new information.

This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about Colchicine Tablets, USP when you start taking it and at regular checkups. What is the most important information that I should know about Colchicine Tablets, USP?

Colchicine Tablets, USP can cause serious side effects or death if levels of colchicine are too high in your body. Taking certain medicines with Colchicine Tablets, USP can cause your level of colchicine to be too high, especially if you have kidney or liver problems. Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems.

Your dose of Colchicine Tablets, USP may need to be changed. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Even medicines that you take for a short period of time, such as antibiotics, can interact with Colchicine Tablets, USP and cause serious side effects or death.

Talk to your healthcare provider or pharmacist before taking any new medicine. Especially tell your healthcare provider if you take: atazanavir sulfate (Reyataz) cyclosporine (Neoral, Gengraf, Sandimmune) fosamprenavir (Lexiva) with ritonavir indinavir (Crixivan) ketoconazole (Nizoral) nefazodone (Serzone) ritonavir (Norvir) telithromycin (Ketek) clarithromycin (Biaxin) darunavir (Prezista) fosamprenavir (Lexiva) itraconazole (Sporanox) lopinavir/ritonavir (Kaletra) nelfinavir mesylate (Viracept) saquinavir mesylate (Invirase) tipranavir (Aptivus) Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above.

This is not a complete list of all the medicines that can interact with Colchicine Tablets, USP. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Keep Colchicine Tablets, USP out of the reach of children. What are Colchicine Tablets, USP? Colchicine Tablets, USP are a prescription medicine used to: prevent and treat gout flares in adults treat familial Mediterranean fever (FMF) in adults and children age 4 or older Colchicine Tablets, USP are not a pain medicine, and should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.

Who should not take Colchicine Tablets, USP? Do not take Colchicine Tablets, USP if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed.

See "WHAT IS THE MOST IMPORTANT INFORMATION THAT I SHOULD KNOW ABOUT COLCHICINE TABLETS, USP?". What should I tell my healthcare provider before starting Colchicine Tablets, USP? See "WHAT IS THE MOST IMPORTANT INFORMATION THAT I SHOULD KNOW ABOUT COLCHICINE TABLETS, USP?".

Before you take Colchicine Tablets, USP, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems. are pregnant or plan to become pregnant. It is not known if Colchicine Tablets, USP will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. are a male with a female partner who can become pregnant.

Receiving treatment with Colchicine Tablets, USP may be related to infertility in some men that is reversible when treatment is stopped. are breastfeeding or plan to breastfeed. Colchicine passes into your breast milk. You and your healthcare provider should decide if you will take Colchici… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

The evidence for the efficacy of colchicine in patients with chronic gout is derived from the published literature. Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients with gout initiating treatment with urate-lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares.

The efficacy of a low-dosage regimen of oral colchicine (total dose 1.8 mg over one hour) for treatment of gout flares was assessed in a multicenter, randomized, double-blind, placebo-controlled, parallel group, one week, dose-comparison study. Patients meeting American College of Rheumatology criteria for gout were randomly assigned to three groups: high-dose colchicine (1.2 mg, then 0.6 mg hourly × 6 hours [4.8 mg total]); low-dose colchicine (1.2 mg, then 0.6 mg in one hour [1.8 mg total] followed by five placebo doses hourly); or placebo (two capsules, then one capsule hourly × six hours).

Patients took the first dose within 12 hours of the onset of the flare and recorded pain intensity (11 point Likert scale) and adverse events over 72 hours. The efficacy of colchicine was measured based on response to treatment in the target joint, using patient self-assessment of pain at 24 hours following the time of first dose as recorded in the diary. A responder was one who achieved at least a 50% reduction in pain score at the 24 hour postdose assessment relative to the pretreatment score and did not use rescue medication prior to the actual time of 24 hour postdose assessment.

Rates of response were similar for the recommended low-dose treatment group (38%) and the nonrecommended high-dose group (33%) but were higher as compared to the placebo group (16%) as shown in Table 8. Table 8. Number (%) of Responders Based on Target Joint Pain Score at 24 Hours Post First Dose Colchicine Tablets, USP Dose Responders n (%) Placebo n (%) (n=58) % Differences in Proportion Low-Dose (n=74) High-Dose (n=52) Low-Dose vs Placebo (95% CI) High-Dose vs Placebo (95% CI) 28 (38%) 17 (33%) 9 (16%) 22 (8, 37) 17 (1, 33) Figure 1 shows the percentage of patients achieving varying degrees of improvement in pain from baseline at 24 hours. [Figure 1] The evidence for the efficacy of colchicine in patients with FMF is derived from the published literature.

Three randomized, placebo-controlled studies were identified. The three placebo-controlled studies randomized a total of 48 adult patients diagnosed with FMF and reported similar efficacy endpoints as well as inclusion and exclusion criteria. One of the studies randomized 15 patients with FMF to a six month crossover study during which five patients discontinued due to study noncompliance.

The ten patients completing the study experienced five attacks over the course of 90 days while treated with colchicine compared to 59 attacks over the course of 90 days while treated with placebo. Similarly, the second study randomized 22 patients with FMF to a four month crossover study during which nine patients discontinued due to lack of efficacy while receiving placebo or study noncompliance. The 13 patients completing the study experienced 18 attacks over the course of 60 days while treated with colchicine compared to 68 attacks over the course of 60 days while treated with placebo.

The third study was discontinued after an interim analysis of six of the 11 patients enrolled had completed the study; results could not be confirmed. Open-label experience with colchicine in adults and children with FMF is consistent with the randomized, controlled trial experience and was utilized to support information on the safety profile of colchicine and for dosing recommendations.

🔒 Drug Abuse and Dependence 10 words ▾

Tolerance, abuse or dependence with colchicine has not been reported.

🧪 Nonclinical Toxicology ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Two year studies were conducted in mice and rats to assess the carcinogenic potential of colchicine. No evidence of colchicine-related tumorigenicity was observed in mice or rats at colchicine oral doses up to 3 and 2 mg/kg/day, respectively (approximately six and eight times, respectively, the maximum recommended human dose of 2.4 mg on a mg/m2 basis). Mutagenesis Colchicine was negative for mutagenicity in the bacterial reverse mutation assay.

In a chromosomal aberration assay in cultured human white blood cells, colchicine treatment resulted in the formation of micronuclei. Since published studies demonstrated that colchicine induces aneuploidy from the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed. Impairment of Fertility No studies of colchicine effects on fertility were conducted with Colchicine Tablets, USP.

However, published nonclinical studies demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Reproductive studies also reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division and normal cleavage in females when exposed to colchicine. Colchicine administered to pregnant animals resulted in fetal death and teratogenicity.

These effects were dose-dependent, with the timing of exposure critical for the effects on embryofetal development. The nonclinical doses evaluated were generally higher than an equivalent human therapeutic dose, but safety margins for reproductive and developmental toxicity could not be determined.

📄 Package Label / Principal Display Panel 1 words ▾

249

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Colchicine — the program that covers self-administered drugs. 15 manufacturers.
⚠️ 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 Colchicine. 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
$13.12M
Claims incl. refills
405.6K
Beneficiaries
294.4K
Spend / beneficiary
$44.59
Spend / claim
$32.35
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for COLCHICINE — the ingredient across all brands.

Top reported reactions

Diarrhoea2,429
Nausea1,801
Fatigue1,630
Arthralgia1,354
Dyspnoea1,351
Acute Kidney Injury1,307
Headache1,265

Age at onset

Neonate44
Infant21
Child106
Adolescent78
Adult2,391
Elderly1,896

Reporter sex

26,301 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Death3,265
Life-threatening1,671
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,504 1,123
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by direct rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
direct rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72189-0248-90 · direct 72189-0250-90 · DIRECT →
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.