Thiola Tablet, Sugar Coated
NDC Package 0178-0900-01

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

Package Information

Thiola (tiopronin) tablets is a medication used to prevent kidney stones in people with a certain inherited disorder (cystinuria). This formulation utilizes a tablet, sugar coated delivery system. Marketed by Mission Pharmacal Company, this product is identified by NDC 0178-0900 and is authorized under FDA application NDA019569.

Identification & Billing

NDC Package Code
0178-0900-01
Package Description
100 TABLET, SUGAR COATED in 1 BOTTLE
Product Code
0178-0900
11-Digit Billing Format
00178090001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thiola
Non-Proprietary Name
Tiopronin
Substance Name
Tiopronin
Dosage Form
Tablet, Sugar Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar.
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
Mission Pharmacal Company
Product Type
Human Prescription Drug
FDA Application #
NDA019569
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-11-1988
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 0178-0900-01 identifies a specific commercial package of 100 tablet, sugar coated in 1 bottle of Thiola, a human prescription drug labeled by Mission Pharmacal Company. This tablet, sugar coated 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 Mission Pharmacal Company on August 11, 1988. 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 Mission Pharmacal Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00178090001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0178-0900-01
11-Digit CMS (5-4-2)
00178-0900-01

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