Colchicine Tablet, Film Coated
NDC Package 72789-572-30

11-digit billing NDC: 72789057230 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Colchicine tablets is patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with  P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). This formulation utilizes a tablet, film coated delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-572 and is authorized under FDA application ANDA208993.

Identification & Billing

NDC Package Code
72789-572-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
72789-572
11-Digit Billing Format
72789057230
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 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
Patients with renal or hepatic impairment should not be given colchicine tablets 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.

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208993
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-13-2021
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 72789-572-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Colchicine, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Pd-rx Pharmaceuticals, Inc. on August 13, 2021. The current certification is valid through December 31, 2027.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789057230. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
72789-572-30
11-Digit CMS (5-4-2)
72789-0572-30

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