Colchicine Capsule
NDC Package 67046-0889-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Colchicine capsules is a medication used to prevent or treat gout attacks (flares). This formulation utilizes a capsule delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0889 and is authorized under FDA application NDA204820.

Identification & Billing

NDC Package Code
67046-0889-3
Package Description
30 CAPSULE in 1 BLISTER PACK
Product Code
67046-0889
11-Digit Billing Format
67046088903
RxNorm Crosswalk
RxCUI: 1550940 - colchicine 0.6 MG Oral Capsule

Clinical Specifications

Proprietary Name
Colchicine
Non-Proprietary Name
Colchicine
Substance Name
Colchicine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLCHICINE .6 mg/1
Pharmacologic Class
Usage Information
This medication is used to prevent or treat gout attacks (flares). Usually gout symptoms develop suddenly and involve only one or a few joints. The big toe, knee, or ankle joints are most often affected. Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, the uric acid may form hard crystals in your joints. Colchicine works by decreasing swelling and lessening the build up of uric acid crystals that cause pain in the affected joint(s). This medication is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). It is thought to work by decreasing your body's production of a certain protein (amyloid A) that builds up in people with familial Mediterranean fever. Colchicine is not a pain medication and should not be used to relieve other causes of pain.

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
NDA204820
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-27-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-0889-3 identifies a specific commercial package of 30 capsule in 1 blister pack of Colchicine, a human prescription drug labeled by Coupler Llc. This capsule is formulated for oral use and contains colchicine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Coupler Llc on January 27, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent or treat gout attacks (flares). Usually gout symptoms develop suddenly and involve only one or a few joints. The big toe, knee, or ankle joints are most often affected. Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, the uric acid may form hard crystals in your joints. Colchicine works by decreasing swelling and lessening the build up of uric acid crystals that cause pain in the affected joint(s). This medication is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). It is thought to work by decreasing your body's production of a certain protein (amyloid A) that builds up in people with familial Mediterranean fever. Colchicine is not a pain medication and should not be used to relieve other causes of pain.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046088903. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
67046-0889-3
11-Digit CMS (5-4-2)
67046-0889-03

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.