ZORYVE
- Product NDC
- 80610-115
- 11-digit product format
- 806100115
- Labeler code
- 80610
- Product ID
- 80610-115_f310345f-118f-4366-92d8-40ed96ea318b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- roflumilast
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Arcutis Biotherapeutics, Inc.
- Application
- NDA215985
- Marketing category
- NDA
- Marketing start
- 2024-07-09
- Substance
- ROFLUMILAST
- Active strength
- 1.5 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 | 1.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0P6C6ZOP5U |
| Rxcui | 2608534, 2608539, 2687710, 2687712, 2725121, 2725123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80610-115 | ZORYVE (ROFLUMILAST) CREAM [ARCUTIS BIOTHERAPEUTICS, INC.] | 9 | Current NDC, 4 package rows | 20240815_ec1bb0d1-f38a-4080-831a-68791d1d1fdb.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 |
|---|
| 80610-115-05 | 80610011505 | 5 g in 1 TUBE | 5 g | | | | Historical |
| 80610-115-60 | 80610011560 | 1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE | 1 tube | 2024-07-09 | No | No | Current |
| 80610-115-96 | 80610011596 | 6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05) | 6 tube | 2024-07-09 | No | No | Current |