What is NDC 75626-001?

75626-001 is the product NDC for Lupkynis (voclosporin), Voclosporin 7.9 mg/1 capsule, listed with the FDA by Aurinia Pharma U.S., Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurinia Pharma U.S., Inc., NDC labeler code 75626. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lupkynis?

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.

Lupkynis NDC 75626-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)75626-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75626-0001Add 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
75626-001-02	75626000102	3 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACKMarketed from Jan 22, 2021

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): Lupkynis
Generic name (nonproprietary): voclosporin
Active ingredients: Voclosporin — 7.9 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurinia Pharma U.S., Inc.NDC labeler code 75626
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213716
Marketing start: Jan 22, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 75626-001_59e563df-ed2e-4a55-e063-6294a90a0b51SPL ID 59e563df-ed2e-4a55-e063-6294a90a0b51SPL set ID 9f489295-1156-52c7-5fd0-5c4c52f9b813RxCUI 2475400, 2475406UNII 2PN063X6B1
Pharmacologic class: Calcineurin Inhibitor Immunosuppressant

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

N475626000102 followed by a unit qualifier and the quantity

Package 75626-0001-02. 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 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). ( 1 , 14 ) Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYN…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75626-001

What is NDC 75626-001?: 75626-001 is the product NDC for Lupkynis (voclosporin), Voclosporin 7.9 mg/1 capsule, listed with the FDA by Aurinia Pharma U.S., Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lupkynis (Voclosporin).
What is the active ingredient?: Voclosporin.
Who is the labeler?: Aurinia Pharma U.S., Inc., NDC labeler code 75626. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lupkynis?: 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.

Lupkynis (Voclosporin) NDC 75626-001