What is NDC 0469-1425?

0469-1425 is the product NDC for Xospata (gilteritinib), Gilteritinib fumarate 40 mg/1 tablet, listed with the FDA by Astellas Pharma US, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xospata?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xospata NDC 0469-1425 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0469-1425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00469-1425Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0469-1425-21	0046914252100469142521	1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLEMarketed from Apr 30, 2022 · Sample package
0469-1425-90	0046914259000469142590	1 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLEMarketed from Nov 29, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Xospata
Generic name (nonproprietary): gilteritinib
Active ingredients: Gilteritinib fumarate — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Astellas Pharma US, Inc.NDC labeler code 0469
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211349
Marketing start: Nov 29, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 0469-1425_cee167a0-32ac-4cc2-957b-a10b685ed206SPL ID cee167a0-32ac-4cc2-957b-a10b685ed206

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400469142521 followed by a unit qualifier and the quantity

Package 00469-1425-21. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0469-1425

What is NDC 0469-1425?: 0469-1425 is the product NDC for Xospata (gilteritinib), Gilteritinib fumarate 40 mg/1 tablet, listed with the FDA by Astellas Pharma US, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xospata (Gilteritinib).
What is the active ingredient?: Gilteritinib fumarate.
Who is the labeler?: Astellas Pharma US, Inc., NDC labeler code 0469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xospata?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Xospata (Gilteritinib) NDC 0469-1425