Attruby Tablet, Film Coated
NDC Package 82228-712-30

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

Package Information

Attruby (acoramidis hydrochloride) tablets is aTTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. This formulation utilizes a tablet, film coated delivery system. Marketed by Bridgebio Pharma, Inc., this product is identified by NDC 82228-712 and is authorized under FDA application NDA216540.

Identification & Billing

NDC Package Code
82228-712-30
Package Description
1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE
Product Code
82228-712
11-Digit Billing Format
82228071230

Clinical Specifications

Proprietary Name
Attruby
Non-Proprietary Name
Acoramidis Hydrochloride
Substance Name
Acoramidis Hydrochloride
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)
ACORAMIDIS HYDROCHLORIDE 356 mg/1
Pharmacologic Class
Usage Information
ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

Regulatory & Marketing

Labeler Name
Bridgebio Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216540
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-22-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82228-712). Click a package code to view its specific billing and regulatory data.

82228-712-28
4 DOSE PACK in 1 CARTON / 1 BLISTER PACK in 1 DOSE PACK / 28 TABLET, FILM COATED in 1 BLISTER PACK

* 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 82228-712-30 identifies a specific commercial package of 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle of Attruby, a human prescription drug labeled by Bridgebio Pharma, Inc.. This tablet, film coated is formulated for oral use and contains acoramidis 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 Bridgebio Pharma, Inc. on November 22, 2024. The current certification is valid through December 31, 2027.

How is this Bridgebio Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82228071230. 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)
82228-712-30
11-Digit CMS (5-4-2)
82228-0712-30

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