Colchicine Tablet
NDC Package 65162-710-09
Package Information
Colchicine tablets is a medication used to prevent or treat gout attacks (flares). This formulation utilizes a tablet delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-710 and is authorized under FDA application ANDA204711.
Identification & Billing
- RxCUI: 197541 - colchicine 0.6 MG Oral Tablet
- RxCUI: 197541 - colchicine 600 MCG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65162 - Amneal Pharmaceuticals Llc
- 65162-710 - Colchicine
- 65162-710-09 - 90 TABLET in 1 BOTTLE
- 65162-710 - Colchicine
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (65162-710). Click a package code to view its specific billing and regulatory data.
* 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 65162-710-09 identifies a specific commercial package of 90 tablet in 1 bottle of Colchicine, a human prescription drug labeled by Amneal Pharmaceuticals Llc. 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 Amneal Pharmaceuticals Llc on September 30, 2016. 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 Amneal Pharmaceuticals Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162071009. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.