Emcitate Tablet, For Suspension
NDC Package 87216-0100-1

11-digit billing NDC: 87216010001
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Emcitate (tiratricol) tablets is eMCITATE is indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome). This formulation utilizes a tablet, for suspension delivery system. Marketed by Rare Thyroid Therapeutics International Ab, this product is identified by NDC 87216-0100 and is authorized under FDA application NDA220963.

Identification & Billing

NDC Package Code
87216-0100-1
Package Description
6 BLISTER PACK in 1 CARTON / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (87216-0100-0)
Product Code
87216-0100
11-Digit Billing Format
87216010001

Clinical Specifications

Proprietary Name
Emcitate
Non-Proprietary Name
Tiratricol
Substance Name
Tiratricol
Dosage Form
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TIRATRICOL 350 ug/1
Usage Information
EMCITATE is indicated for the treatment of peripheral thyrotoxicosis in adults and pediatric patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley syndrome).

Regulatory & Marketing

Labeler Name
Rare Thyroid Therapeutics International Ab
Product Type
Human Prescription Drug
FDA Application #
NDA220963
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-26-2026
Listing Expiration
12-31-2027
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 87216-0100-1 identifies a specific commercial package of 6 blister pack in 1 carton / 10 tablet, for suspension in 1 blister pack (87216-0100-0) of Emcitate, a human prescription drug labeled by Rare Thyroid Therapeutics International Ab. This tablet, for suspension is formulated for oral use and contains tiratricol 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 Rare Thyroid Therapeutics International Ab on October 26, 2026. The current certification is valid through December 31, 2027.

How is this Rare Thyroid Therapeutics International Ab product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87216010001. 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 (5-4-1)
87216-0100-1
11-Digit CMS (5-4-2)
87216-0100-01

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