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  5. NDC Package Code: 60468-007-03 Sephience

NDC Package 60468-007-03 Sephience

Sepiapterin Powder 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:
60468-007-03
Package Description:
30 PACKET in 1 CARTON / 1 POWDER in 1 PACKET (60468-007-01)
Product Code:
60468-007
Proprietary Name:
Sephience
Non-Proprietary Name:
Sepiapterin
Substance Name:
Sepiapterin
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.
11-Digit NDC Billing Format:
60468000703
Product Type:
Human Prescription Drug
Labeler Name:
Allphamed Pharbil Arzneimittel Gmbh
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
SEPIAPTERIN 250 mg/1
Sample Package:
No
FDA Application Number:
NDA219666
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
07-28-2025
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 60468-007-03?

The NDC Packaged Code 60468-007-03 is assigned to a 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. The product's dosage form is powder and is administered via oral form.

Is NDC 60468-007 included in the NDC Directory?

Yes, Sephience with product code 60468-007 is active and included in the NDC Directory. The product was first marketed by Allphamed Pharbil Arzneimittel Gmbh on July 28, 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 60468-007-03?

The 11-digit format is 60468000703. 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 5-3-2 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
5-3-260468-007-035-4-260468-0007-03