Sephience Powder
NDC Package 60468-007-03

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

Package Information

Sephience (sepiapterin) powders is sEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). This formulation utilizes a powder delivery system. Marketed by Allphamed Pharbil Arzneimittel Gmbh, this product is identified by NDC 60468-007 and is authorized under FDA application NDA219666.

Identification & Billing

NDC Package Code
60468-007-03
Package Description
30 PACKET in 1 CARTON / 1 POWDER in 1 PACKET (60468-007-01)
Product Code
60468-007
11-Digit Billing Format
60468000703
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sephience
Non-Proprietary Name
Sepiapterin
Substance Name
Sepiapterin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SEPIAPTERIN 250 mg/1
Usage Information
SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet.

Regulatory & Marketing

Labeler Name
Allphamed Pharbil Arzneimittel Gmbh
Product Type
Human Prescription Drug
FDA Application #
NDA219666
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-28-2025
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 60468-007-03 identifies a specific commercial package of 30 packet in 1 carton / 1 powder in 1 packet (60468-007-01) of Sephience, a human prescription drug labeled by Allphamed Pharbil Arzneimittel Gmbh. This powder is formulated for oral use and contains sepiapterin 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 Allphamed Pharbil Arzneimittel Gmbh on July 28, 2025. The current certification is valid through December 31, 2026.

How is this Allphamed Pharbil Arzneimittel Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60468000703. 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)
60468-007-03
11-Digit CMS (5-4-2)
60468-0007-03

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