Xospata Tablet
NDC Package 0469-1425-90

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

Xospata (gilteritinib) tablets is gilteritinib is used to treat acute myeloid leukemia (AML). This formulation utilizes a tablet delivery system. Marketed by Astellas Pharma Us, Inc., this product is identified by NDC 0469-1425 and is authorized under FDA application NDA211349.

Identification & Billing

NDC Package Code
0469-1425-90
Package Description
1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE
Product Code
0469-1425
11-Digit Billing Format
00469142590
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xospata
Non-Proprietary Name
Gilteritinib
Substance Name
Gilteritinib Fumarate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GILTERITINIB FUMARATE 40 mg/1
Usage Information
Gilteritinib is used to treat acute myeloid leukemia (AML). It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Astellas Pharma Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211349
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-29-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0469-1425). Click a package code to view its specific billing and regulatory data.

0469-1425-21
1 BOTTLE in 1 CARTON / 21 TABLET 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 0469-1425-90 identifies a specific commercial package of 1 bottle in 1 carton / 90 tablet in 1 bottle of Xospata, a human prescription drug labeled by Astellas Pharma Us, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains gilteritinib fumarate 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 Astellas Pharma Us, Inc. on November 29, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Gilteritinib is used to treat acute myeloid leukemia (AML). It works by slowing or stopping the growth of cancer cells.

How is this Astellas Pharma Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00469142590. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0469-1425-90
11-Digit CMS (5-4-2)
00469-1425-90

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