Tolcapone Tablet, Film Coated
NDC Package 68682-938-90

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

Package Information

Tolcapone tablets is a medication used with other medications (levodopa/carbidopa) to treat Parkinson's disease. This formulation utilizes a tablet, film coated delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-938 and is authorized under FDA application NDA020697.

Identification & Billing

NDC Package Code
68682-938-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
68682-938
11-Digit Billing Format
68682093890
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
RxCUI: 200220 - tolcapone 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tolcapone
Non-Proprietary Name
Tolcapone
Substance Name
Tolcapone
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)
TOLCAPONE 100 mg/1
Pharmacologic Class
Usage Information
This medication is used with other medications (levodopa/carbidopa) to treat Parkinson's disease. Tolcapone belongs to a class of drugs known as COMT inhibitors. Many people taking levodopa for Parkinson's have problems with the effects of the levodopa wearing off between scheduled doses, causing symptoms to return or worsen. Tolcapone blocks a certain natural substance (COMT enzyme) that breaks down levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn't wear off before the next dose.

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA020697
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
07-27-2004
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 68682-938-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Tolcapone, a human prescription drug labeled by Oceanside Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated is formulated for oral use and contains tolcapone 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 Oceanside Pharmaceuticals on July 27, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with other medications (levodopa/carbidopa) to treat Parkinson's disease. Tolcapone belongs to a class of drugs known as COMT inhibitors. Many people taking levodopa for Parkinson's have problems with the effects of the levodopa wearing off between scheduled doses, causing symptoms to return or worsen. Tolcapone blocks a certain natural substance (COMT enzyme) that breaks down levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn't wear off before the next dose.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682093890. 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:

10-Digit Format (5-3-2)
68682-938-90
11-Digit CMS (5-4-2)
68682-0938-90

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