Tiopronin Tablet, Delayed Release
NDC Package 44523-054-01

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 Biocomp Pharma, Inc., this product is identified by NDC 44523-054 and is authorized under FDA application NDA211843.

Identification & Billing

NDC Package Code
44523-054-01
Package Description
300 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
44523-054
11-Digit Billing Format
44523005401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
300 EA
RxNorm Crosswalk

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 100 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
Biocomp Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211843
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-05-2024
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 44523-054-01 identifies a specific commercial package of 300 tablet, delayed release in 1 bottle of Tiopronin, a human prescription drug labeled by Biocomp Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 300 billable units per package. 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 Biocomp Pharma, Inc. on December 05, 2024. 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 Biocomp Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44523005401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 300 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)
44523-054-01
11-Digit CMS (5-4-2)
44523-0054-01

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