Tiopronin Tablet, Delayed Release
NDC Package 60219-2009-9

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

Package Information

Tiopronin tablets is a medication used to prevent kidney stones in people with a certain inherited disorder (cystinuria). This formulation utilizes a tablet, delayed release delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 60219-2009 and is authorized under FDA application ANDA216278.

Identification & Billing

NDC Package Code
60219-2009-9
Package Description
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
60219-2009
11-Digit Billing Format
60219200909
RxNorm Crosswalk
RxCUI: 2178079 - tiopronin 300 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Tiopronin
Non-Proprietary Name
Tiopronin
Substance Name
Tiopronin
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIOPRONIN 300 mg/1
Pharmacologic Class
Usage Information
This medication is used to prevent kidney stones in people with a certain inherited disorder (cystinuria). Cystinuria occurs when there is too much of a certain natural substance (the amino acid cystine) in the urine, leading to formation of kidney stones. Tiopronin works by making cystine more dissolvable in the urine. This medication should be used in combination with other methods to prevent kidney stones (such as drinking plenty of water, taking alkali treatment, following a special diet).

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216278
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2025
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 60219-2009-9 identifies a specific commercial package of 90 tablet, delayed release in 1 bottle of Tiopronin, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This tablet, delayed release is formulated for oral use and contains tiopronin 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 Ny Llc on January 02, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent kidney stones in people with a certain inherited disorder (cystinuria). Cystinuria occurs when there is too much of a certain natural substance (the amino acid cystine) in the urine, leading to formation of kidney stones. Tiopronin works by making cystine more dissolvable in the urine. This medication should be used in combination with other methods to prevent kidney stones (such as drinking plenty of water, taking alkali treatment, following a special diet).

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60219200909. 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)
60219-2009-9
11-Digit CMS (5-4-2)
60219-2009-09

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