What is NDC 80610-105?

80610-105 is the product NDC for Zoryve (roflumilast), Roflumilast .5 mg/g cream, listed with the FDA by Arcutis Biotherapeutics, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Arcutis Biotherapeutics, Inc., NDC labeler code 80610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zoryve?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zoryve NDC 80610-105 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80610-105Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80610-0105Add 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
80610-105-60	80610010560	1 TUBE in 1 CARTON (80610-105-60) / 60 g in 1 TUBEMarketed from Oct 4, 2025
80610-105-96	80610010596	6 TUBE in 1 CARTON (80610-105-96) / 5 g in 1 TUBE (80610-105-05)Marketed from Oct 4, 2025

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): Zoryve
Generic name (nonproprietary): roflumilast
Active ingredients: Roflumilast — .5 mg/g
Dosage form: Cream
Route: Topical
Labeler: Arcutis Biotherapeutics, Inc.NDC labeler code 80610
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215985
Marketing start: Oct 4, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 80610-105_85900c39-1416-4988-b221-d493feae9dcaSPL ID 85900c39-1416-4988-b221-d493feae9dcaSPL set ID ec1bb0d1-f38a-4080-831a-68791d1d1fdbRxCUI 2608534, 2608539, 2687710, 2687712, 2725121, 2725123UNII 0P6C6ZOP5U
Pharmacologic class: Phosphodiesterase 4 Inhibitor

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480610010560 followed by a unit qualifier and the quantity

Package 80610-0105-60. 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 Jul 20, 2026.

Indications (excerpt from the label)

ZORYVE cream is a phosphodiesterase 4 inhibitor: Plaque Psoriasis ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 2 years of age and older. ( 1.1 ) Atopic Dermatitis ZORYVE cream, 0.15%, is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ( 1.2 ) ZORYVE cream, 0.05%, is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. ( 1.2 ) 1.1 Plaque Psoriasis ZORYVE ® cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80610-105

What is NDC 80610-105?: 80610-105 is the product NDC for Zoryve (roflumilast), Roflumilast .5 mg/g cream, listed with the FDA by Arcutis Biotherapeutics, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zoryve (Roflumilast).
What is the active ingredient?: Roflumilast.
Who is the labeler?: Arcutis Biotherapeutics, Inc., NDC labeler code 80610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zoryve?: 3 other product NDCs are listed under this name. See all Zoryve NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zoryve NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zoryveroflumilast	Roflumilast 1.5 mg/g	CreamTopical	Arcutis Biotherapeutics, Inc.	80610-115	80610-0115-6080610-0115-96
Zoryveroflumilast	Roflumilast 3 mg/g	Aerosol, FoamTopical	Arcutis Biotherapeutics, Inc.	80610-430	80610-0430-60
Zoryveroflumilast	Roflumilast 3 mg/g	CreamTopical	Arcutis Biotherapeutics, Inc.	80610-130	80610-0130-6080610-0130-96

Other NDCs under NDA 215985

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 215985
Product	Strength	Form · route	Labeler	Product NDC
Zoryveroflumilast	Roflumilast 3 mg/g	CreamTopical	Arcutis Biotherapeutics, Inc.	80610-130
Zoryveroflumilast	Roflumilast 1.5 mg/g	CreamTopical	Arcutis Biotherapeutics, Inc.	80610-115

Zoryve (Roflumilast) NDC 80610-105

NDC codes

Product information

Billing references

Product label

About NDC 80610-105

Other NDCs under NDA 215985

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NDC codes

Product information

Billing references

Product label

About NDC 80610-105

Related NDCs: other Zoryve products

Other NDCs under NDA 215985