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  5. NDC Package Code: 73289-0071-2 Zelvysia

NDC Package 73289-0071-2 Zelvysia

Sapropterin Dihydrochloride Powder, For Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Zelvysia
Non-Proprietary Name:
Sapropterin Dihydrochloride
Substance Name:
Sapropterin Dihydrochloride
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.
11-Digit NDC Billing Format:
73289007102
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Aucta Pharmaceuticals, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
SAPROPTERIN DIHYDROCHLORIDE 500 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA218645
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-29-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 73289-0071-2?

The NDC Packaged Code 73289-0071-2 is assigned to a 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.. The product's dosage form is powder, for solution and is administered via oral form.

Is NDC 73289-0071 included in the NDC Directory?

Yes, Zelvysia with product code 73289-0071 is active and included in the NDC Directory. The product was first marketed by Aucta Pharmaceuticals, Inc. on April 29, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 73289-0071-2?

The 11-digit format is 73289007102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-173289-0071-25-4-273289-0071-02