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 AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

roflumilast 3 mg/g

Manufacturer
Arcutis Biotherapeutics, Inc.

Identifiers & Regulatory

Product NDC 80610-430
Product ID 80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217242
Listing Expiration 2027-12-31
Marketing Start 2023-12-15

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 80610430
Hyphenated Format 80610-430

Supplemental Identifiers

RxCUI
2671682 2671684
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 NDA217242 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN
source: ndc

Packages (1)

80610-430-60 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN

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": "e16c73c6-8f2a-470b-9504-83b183e9df16", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["2671682", "2671684"], "spl_set_id": ["f9e0b4a9-a227-4947-b00c-41fb18d16589"], "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 CAN in 1 CARTON (80610-430-60)  / 60 g in 1 CAN", "package_ndc": "80610-430-60", "marketing_start_date": "20231215"}], "brand_name": "ZORYVE", "product_id": "80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "80610-430", "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": "NDA217242", "marketing_category": "NDA", "marketing_start_date": "20231215", "listing_expiration_date": "20271231"}