Zelvysia Powder, For Solution
NDC Package 73289-0071-2

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

Package Information

Zelvysia (sapropterin dihydrochloride) powders is a medication used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). This formulation utilizes a powder, for solution delivery system. Marketed by Aucta Pharmaceuticals, Inc., this product is identified by NDC 73289-0071 and is authorized under FDA application ANDA218645.

Identification & Billing

NDC Package Code
73289-0071-2
Package Description
30 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0071-1)
Product Code
73289-0071
11-Digit Billing Format
73289007102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1111018 - sapropterin dihydrochloride 100 MG Powder for Oral Solution
  • RxCUI: 1653217 - sapropterin dihydrochloride 500 MG Powder for Oral Solution
  • RxCUI: 2712689 - Zelvysia 100 MG Powder for Oral Solution
  • RxCUI: 2712689 - sapropterin dihydrochloride 100 MG Powder for Oral Solution [Zelvysia]
  • RxCUI: 2712691 - Zelvysia 500 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Zelvysia
Non-Proprietary Name
Sapropterin Dihydrochloride
Substance Name
Sapropterin Dihydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SAPROPTERIN DIHYDROCHLORIDE 500 mg/1
Pharmacologic Class
Usage Information
This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It helps remove a certain chemical (phenylalanine) from the body. Too much phenylalanine in the body can cause brain damage.

Regulatory & Marketing

Labeler Name
Aucta Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218645
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-29-2025
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 73289-0071-2 identifies a specific commercial package of 30 packet in 1 carton / 1 powder, for solution in 1 packet (73289-0071-1) of Zelvysia, a human prescription drug labeled by Aucta Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This powder, for solution is formulated for oral use and contains sapropterin dihydrochloride 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 Aucta Pharmaceuticals, Inc. on April 29, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It helps remove a certain chemical (phenylalanine) from the body. Too much phenylalanine in the body can cause brain damage.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73289007102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
73289-0071-2
11-Digit CMS (5-4-2)
73289-0071-02

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