Colchicine Tablet, Film Coated
NDC Package 72189-687-03

11-digit billing NDC: 72189068703 · Billing unit: EA · 3 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Colchicine tablets is 1.1 Gout FlaresColchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. This formulation utilizes a tablet, film coated delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-687 and is authorized under FDA application ANDA208993.

Identification & Billing

NDC Package Code
72189-687-03
Package Description
3 TABLET, FILM COATED in 1 BOTTLE
Product Code
72189-687
11-Digit Billing Format
72189068703
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, 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLCHICINE .6 mg/1
Pharmacologic Class
Usage Information
1.1 Gout FlaresColchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF)Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA208993
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2026
Listing Expiration
12-31-2027
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 72189-687-03 identifies a specific commercial package of 3 tablet, film coated 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, film coated 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 August 27, 2026. The current certification is valid through December 31, 2027.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189068703. 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)
72189-687-03
11-Digit CMS (5-4-2)
72189-0687-03

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