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  5. NDC Package Code: 0310-0640-60 Koselugo

NDC Package 0310-0640-60 Koselugo

Selumetinib Granule 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:
0310-0640-60
Package Description:
60 GRANULE in 1 BOTTLE
Product Code:
0310-0640
Proprietary Name:
Koselugo
Non-Proprietary Name:
Selumetinib
Substance Name:
Selumetinib
Usage Information:
KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
11-Digit NDC Billing Format:
00310064060
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Astrazeneca Pharmaceuticals Lp
Dosage Form:
Granule - A small particle or grain.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
SELUMETINIB 7.5 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA219943
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
09-10-2025
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 0310-0640-60?

The NDC Packaged Code 0310-0640-60 is assigned to a package of 60 granule in 1 bottle of Koselugo, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is granule and is administered via oral form.

Is NDC 0310-0640 included in the NDC Directory?

Yes, Koselugo with product code 0310-0640 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on September 10, 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 0310-0640-60?

The 11-digit format is 00310064060. 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 4-4-2 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
4-4-20310-0640-605-4-200310-0640-60