Colchicine Tablet
NDC Package 72189-331-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Colchicine tablets is a medication used to prevent or treat gout attacks (flares). This formulation utilizes a tablet delivery system. Marketed by Direct Rx, this product is identified by NDC 72189-331 and is authorized under FDA application ANDA209876.

Identification & Billing

NDC Package Code
72189-331-03
Package Description
3 TABLET in 1 BOTTLE
Product Code
11-Digit Billing Format
72189033103
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colchicine
Non-Proprietary Name
Colchicine
Substance Name
Colchicine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
ANDA209876
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2022
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 72189-331-03 identifies a specific commercial package of 3 tablet in 1 bottle of Colchicine, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This tablet 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 Direct Rx on March 01, 2022. 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 Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189033103. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. 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 (5-3-2)
72189-331-03
11-Digit CMS (5-4-2)
72189-0331-03

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