ZORYVE
- Product NDC
- 80610-430
- 11-digit product format
- 806100430
- Labeler code
- 80610
- Product ID
- 80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- roflumilast
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Arcutis Biotherapeutics, Inc.
- Application
- NDA217242
- Marketing category
- NDA
- Marketing start
- 2023-12-15
- Substance
- ROFLUMILAST
- Active strength
- 3 mg/g
- Pharmacologic classes
- Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZORYVE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROFLUMILAST | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0P6C6ZOP5U |
| Rxcui | 2671682, 2671684 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80610-430-60 | ZORYVE | 60 g in 1 CAN | AEROSOL, FOAM | 60 | | 6 |
| 80610-430-60 | ZORYVE | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80610-430 | ZORYVE (ROFLUMILAST) AEROSOL, FOAM [ARCUTIS BIOTHERAPEUTICS, INC.] | 4 | Current NDC, 2 package rows | 20250529_f9e0b4a9-a227-4947-b00c-41fb18d16589.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80610-430-60 | 80610043060 | 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN | 1 can | 2023-12-15 | No | No | Current |