Prescription drug · NDA
Zoryve (Roflumilast) NDC 80610-430
Roflumilast 3 mg/g · Aerosol, Foam · Topical · Arcutis Biotherapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80610-430-60 | 80610043060 | 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CANMarketed from Dec 15, 2023 |
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 — 3 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Arcutis Biotherapeutics, Inc.NDC labeler code 80610
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217242
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 80610-430_55ef42d5-d5c8-4f99-a554-e45726b44ac5SPL ID 55ef42d5-d5c8-4f99-a554-e45726b44ac5SPL set ID f9e0b4a9-a227-4947-b00c-41fb18d16589RxCUI 2671682, 2671684UNII 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
N480610043060followed by a unit qualifier and the quantityPackage 80610-0430-60. 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 .
Indications (excerpt from the label)
ZORYVE topical foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ( 1.1 ) plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ( 1.2 ) 1.1 Seborrheic Dermatitis ZORYVE ® topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. 1.2 Plaque Psoriasis ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 80610-430
- What is NDC 80610-430?
- 80610-430 is the product NDC for Zoryve (roflumilast), Roflumilast 3 mg/g aerosol, foam, listed with the FDA by Arcutis Biotherapeutics, Inc.. It has 1 package NDC, 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.
Related NDCs: other Zoryve products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zoryveroflumilast | Roflumilast .5 mg/g | CreamTopical | Arcutis Biotherapeutics, Inc. | 80610-105 | 80610-0105-6080610-0105-96 |
| Zoryveroflumilast | Roflumilast 1.5 mg/g | CreamTopical | Arcutis Biotherapeutics, Inc. | 80610-115 | 80610-0115-6080610-0115-96 |
| Zoryveroflumilast | Roflumilast 3 mg/g | CreamTopical | Arcutis Biotherapeutics, Inc. | 80610-130 | 80610-0130-6080610-0130-96 |