Cuvrior Tablet, Film Coated
NDC Package 81802-001-72

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

Package Information

Cuvrior (trientine tetrahydrochloride) tablets is cUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. This formulation utilizes a tablet, film coated delivery system. Marketed by Orphalan Sa, this product is identified by NDC 81802-001 and is authorized under FDA application NDA215760.

Identification & Billing

NDC Package Code
81802-001-72
Package Description
9 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON (81802-001-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
81802-001
11-Digit Billing Format
81802000172
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
9 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cuvrior
Non-Proprietary Name
Trientine Tetrahydrochloride
Substance Name
Trientine Tetrahydrochloride
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)
TRIENTINE TETRAHYDROCHLORIDE 300 mg/1
Pharmacologic Class
Usage Information
CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine.

Regulatory & Marketing

Labeler Name
Orphalan Sa
Product Type
Human Prescription Drug
FDA Application #
NDA215760
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-14-2022
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 81802-001-72 identifies a specific commercial package of 9 carton in 1 carton / 1 blister pack in 1 carton (81802-001-08) / 8 tablet, film coated in 1 blister pack of Cuvrior, a human prescription drug labeled by Orphalan Sa. This product is billed for "EA" each discreet unit and contains an estimated amount of 9 billable units per package. This tablet, film coated is formulated for oral use and contains trientine tetrahydrochloride 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 Orphalan Sa on September 14, 2022. The current certification is valid through December 31, 2026.

How is this Orphalan Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81802000172. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 9 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)
81802-001-72
11-Digit CMS (5-4-2)
81802-0001-72

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