Pyrukynd Tablet, Film Coated
NDC Package 71334-210-20

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

Package Information

Pyrukynd (mitapivat) tablets is pYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. This formulation utilizes a tablet, film coated delivery system. Marketed by Agios Pharmaceuticals, Inc., this product is identified by NDC 71334-210 and is authorized under FDA application NDA216196.

Identification & Billing

NDC Package Code
71334-210-20
Package Description
4 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-14)
Product Code
71334-210
11-Digit Billing Format
71334021020
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Pyrukynd
Non-Proprietary Name
Mitapivat
Substance Name
Mitapivat
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)
MITAPIVAT 20 mg/1
Pharmacologic Class
Usage Information
PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

Regulatory & Marketing

Labeler Name
Agios Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216196
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-18-2022
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 71334-210-20 identifies a specific commercial package of 4 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack (71334-210-14) of Pyrukynd, a human prescription drug labeled by Agios Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This tablet, film coated is formulated for oral use and contains mitapivat 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 Agios Pharmaceuticals, Inc. on February 18, 2022. The current certification is valid through December 31, 2027.

How is this Agios Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71334021020. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
71334-210-20
11-Digit CMS (5-4-2)
71334-0210-20

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