Colchicine Tablet, Film Coated
NDC Package 47234-0119-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Colchicine tablets is a medication used to prevent or treat gout attacks (flares). This formulation utilizes a tablet, film coated delivery system. Marketed by Takeda Gmbh, this product is identified by NDC 47234-0119.

Identification & Billing

NDC Package Code
47234-0119-1
Package Description
192307 TABLET, FILM COATED in 1 DRUM
Product Code
47234-0119
11-Digit Billing Format
47234011901

Clinical Specifications

Proprietary Name
Colchicine
Non-Proprietary Name
Colchicine
Substance Name
Colchicine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s)
COLCHICINE .6 mg/1
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
Takeda Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-01-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 47234-0119-1 identifies a specific commercial package of 192307 tablet, film coated in 1 drum of Colchicine (UNFINISHED drug), drug for further processing labeled by Takeda Gmbh. This tablet, film coated is formulated for 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 Takeda Gmbh on September 01, 2009. 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 Takeda Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47234011901. 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)
47234-0119-1
11-Digit CMS (5-4-2)
47234-0119-01

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