What is NDC 64406-250?

64406-250 is the product NDC for Skyclarys (omaveloxolone), Omaveloxolone 50 mg/1 capsule, listed with the FDA by Biogen. It has 1 package NDC, shown above in 10- and 11-digit form.

Biogen, NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Skyclarys?

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.

Skyclarys NDC 64406-250 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64406-250Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64406-0250Add 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
64406-250-90	64406025090	90 CAPSULE in 1 BOTTLE (64406-250-90)Marketed from Nov 15, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Skyclarys
Generic name (nonproprietary): omaveloxolone
Active ingredients: Omaveloxolone — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: BiogenNDC labeler code 64406
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216718
Marketing start: Feb 28, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
Identifiers: Product ID 64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0SPL ID 4fa5df55-d5bf-44d1-856e-937b48e69bb0SPL set ID 2709e870-df3d-f30f-e063-6394a90aeda1RxCUI 2631936, 2631942UNII G69Z98951QUPC 0364406250903

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

N464406025090 followed by a unit qualifier and the quantity

Package 64406-0250-90. 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 Apr 6, 2026.

Indications (excerpt from the label)

SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64406-250

What is NDC 64406-250?: 64406-250 is the product NDC for Skyclarys (omaveloxolone), Omaveloxolone 50 mg/1 capsule, listed with the FDA by Biogen. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Skyclarys (Omaveloxolone).
What is the active ingredient?: Omaveloxolone.
Who is the labeler?: Biogen, NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Skyclarys?: 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.

Skyclarys (Omaveloxolone) NDC 64406-250