Trientine Hydrochloride Capsule
NDC Package 43598-459-01

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 are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. This formulation utilizes a capsule delivery system. Marketed by Dr.reddys Laboratories Inc, this product is identified by NDC 43598-459 and is authorized under FDA application ANDA211076.

Identification & Billing

NDC Package Code
43598-459-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
43598-459
11-Digit Billing Format
43598045901
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
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 capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride 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 and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.   Unlike penicillamine, trientine hydrochloride capsules are 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 was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.   Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis.

Regulatory & Marketing

Labeler Name
Dr.reddys Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA211076
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-2019
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 43598-459-01 identifies a specific commercial package of 100 capsule in 1 bottle of Trientine Hydrochloride, a human prescription drug labeled by Dr.reddys Laboratories Inc. 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 Dr.reddys Laboratories Inc on July 03, 2019. The current certification is valid through December 31, 2026.

How is this Dr.reddys Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598045901. 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 (5-3-2)
43598-459-01
11-Digit CMS (5-4-2)
43598-0459-01

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