What is NDC 58468-0251?

58468-0251 is the product NDC for Wayrilz (rilzabrutinib), Rilzabrutinib 400 mg/1 tablet, film coated, listed with the FDA by Genzyme Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.

Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Wayrilz?

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.

Wayrilz NDC 58468-0251 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0251Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0251Add 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
58468-0251-5	58468025105	2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0)Marketed from Aug 29, 2025
58468-0251-6	58468025106	1 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 29, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Wayrilz
Generic name (nonproprietary): rilzabrutinib
Active ingredients: Rilzabrutinib — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219685
Marketing start: Aug 29, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422SPL ID aa3b7d8a-0e0d-481b-bd36-4befaceba422SPL set ID 95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0RxCUI 2722403, 2722409UNII NWN58M4F5T

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

N458468025105 followed by a unit qualifier and the quantity

Package 58468-0251-05. 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

Current FDA label (SPL), effective Aug 26, 2025.

Indications (excerpt from the label)

WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. WAYRILZ is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0251

What is NDC 58468-0251?: 58468-0251 is the product NDC for Wayrilz (rilzabrutinib), Rilzabrutinib 400 mg/1 tablet, film coated, listed with the FDA by Genzyme Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Wayrilz (Rilzabrutinib).
What is the active ingredient?: Rilzabrutinib.
Who is the labeler?: Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Wayrilz?: 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.

Wayrilz (Rilzabrutinib) NDC 58468-0251