zoryve

Generic: roflumilast

Labeler: arcutis biotherapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zoryve
Generic Name roflumilast
Labeler arcutis biotherapeutics, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

roflumilast 3 mg/g

Manufacturer
Arcutis Biotherapeutics, Inc.

Identifiers & Regulatory

Product NDC 80610-130
Product ID 80610-130_f310345f-118f-4366-92d8-40ed96ea318b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215985
Listing Expiration 2027-12-31
Marketing Start 2022-07-29

Pharmacologic Class

Established (EPC)
phosphodiesterase 4 inhibitor [epc]
Mechanism of Action
phosphodiesterase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80610130
Hyphenated Format 80610-130

Supplemental Identifiers

RxCUI
2608534 2608539 2687710 2687712 2725121 2725123
UNII
0P6C6ZOP5U
NUI
N0000182961 N0000182960

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zoryve (source: ndc)
Generic Name roflumilast (source: ndc)
Application Number NDA215985 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE
  • 6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05)
source: ndc

Packages (2)

80610-130-60 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE 80610-130-96 6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05)

Ingredients (1)

roflumilast (3 mg/g)

Linked Drug Pages (1)

ZORYVE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f310345f-118f-4366-92d8-40ed96ea318b", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["2608534", "2608539", "2687710", "2687712", "2725121", "2725123"], "spl_set_id": ["ec1bb0d1-f38a-4080-831a-68791d1d1fdb"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Arcutis Biotherapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80610-130-60)  / 60 g in 1 TUBE", "package_ndc": "80610-130-60", "marketing_start_date": "20220729"}, {"sample": false, "description": "6 TUBE in 1 CARTON (80610-130-96)  / 5 g in 1 TUBE (80610-130-05)", "package_ndc": "80610-130-96", "marketing_start_date": "20220729"}], "brand_name": "ZORYVE", "product_id": "80610-130_f310345f-118f-4366-92d8-40ed96ea318b", "dosage_form": "CREAM", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "80610-130", "generic_name": "roflumilast", "labeler_name": "Arcutis Biotherapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZORYVE", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "3 mg/g"}], "application_number": "NDA215985", "marketing_category": "NDA", "marketing_start_date": "20220729", "listing_expiration_date": "20271231"}