Trientine Hydrochloride Capsule
NDC Package 68475-200-01

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

Package Information

Trientine Hydrochloride capsules is trientine Hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. This formulation utilizes a capsule delivery system. Marketed by Navinta Llc, this product is identified by NDC 68475-200 and is authorized under FDA application ANDA211251.

Identification & Billing

NDC Package Code
68475-200-01
Package Description
1 BOTTLE in 1 CARTON / 100 CAPSULE in 1 BOTTLE
Product Code
68475-200
11-Digit Billing Format
68475020001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Trientine Hydrochloride
Non-Proprietary Name
Trientine Hydrochloride
Substance Name
Trientine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRIENTINE HYDROCHLORIDE 250 mg/1
Pharmacologic Class
Usage Information
Trientine Hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with Trientine Hydrochloride Capsule is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine Hydrochloride Capsule and penicillamine cannot be considered interchangeable. Trientine hydrochloride Capsule should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.Unlike penicillamine, Trientine Hydrochloride Capsule is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, Trientine Hydrochloride Capsule was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.Trientine Hydrochloride Capsule is not indicated for treatment of biliary cirrhosis.

Regulatory & Marketing

Labeler Name
Navinta Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211251
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-05-2020
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 68475-200-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 capsule in 1 bottle of Trientine Hydrochloride, a human prescription drug labeled by Navinta Llc. This capsule is formulated for oral use and contains trientine hydrochloride 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 Navinta Llc on December 05, 2020. The current certification is valid through December 31, 2026.

How is this Navinta Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68475020001. 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)
68475-200-01
11-Digit CMS (5-4-2)
68475-0200-01

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