Koselugo Capsule
NDC Package 0310-0610-28

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

Package Information

Koselugo (selumetinib) capsules is 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). This formulation utilizes a capsule delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-0610 and is authorized under FDA application NDA213756.

Identification & Billing

NDC Package Code
0310-0610-28
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
0310-0610
11-Digit Billing Format
00310061028
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Koselugo
Non-Proprietary Name
Selumetinib
Substance Name
Selumetinib
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SELUMETINIB 10 mg/1
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA213756
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-16-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0310-0610). Click a package code to view its specific billing and regulatory data.

0310-0610-60
60 CAPSULE in 1 BOTTLE

* 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 0310-0610-28 identifies a specific commercial package of 28 capsule in 1 bottle of Koselugo, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This capsule is formulated for oral use and contains selumetinib 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 Astrazeneca Pharmaceuticals Lp on April 16, 2020. The current certification is valid through December 31, 2027.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310061028. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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 (4-4-2)
0310-0610-28
11-Digit CMS (5-4-2)
00310-0610-28

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