FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217242-001ZORYVEROFLUMILAST0.3%FOAM / TOPICALRLD, RS2023-12-15

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217242-001109401422037-06-07Drug product2023-12-26
N217242-001117937962037-06-07Drug product2023-12-26
N217242-001118194962037-06-07U-37732023-12-26
N217242-001118194962037-06-07U-42032023-12-26
N217242-001119924802037-06-07U-37732024-06-26
N217242-001119924802037-06-07U-42032024-06-26
N217242-001120050512037-06-07U-37732024-07-10
N217242-001120050512037-06-07U-42032024-07-10
N217242-001120050522037-06-07Drug product2024-07-10
N217242-001120114372037-06-07Drug product2024-07-10
N217242-001120168482037-06-07Drug product2024-07-10
N217242-001120424872037-06-07Drug product2024-08-16
N217242-001122204092037-06-07Drug product2025-03-07
N217242-001122572422037-06-07Drug product2025-04-22
N217242-001123109562037-06-07U-37732025-06-26
N217242-001123109562037-06-07U-42032025-06-26
N217242-001123369832037-06-07Drug product2025-07-22
N217242-001123904532037-06-07Drug product2025-09-12
N217242-00198840502037-06-07Drug product2023-12-26
N217242-00199077882037-06-07U-37732023-12-26
N217242-00199077882037-06-07U-42032023-12-26
N217242-001111298182037-08-25U-37732023-12-26
N217242-001111298182037-08-25U-42032023-12-26
N217242-001117074542041-12-03U-37732023-12-26
N217242-001123297512041-12-03U-37732025-07-17
N217242-001124537212042-08-19Drug product2025-11-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217242-001NP2026-12-15
N217242-001I-9692028-05-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N217242-001ZORYVE0.3%FOAM / TOPICALRLD, RS2023-12-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N217242-001109401422037-06-07Drug product2023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001117937962037-06-07Drug product2023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001118194962037-06-07U-42032023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001118194962037-06-07U-37732023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001119924802037-06-07U-42032024-06-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001119924802037-06-07U-37732024-06-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120050512037-06-07U-42032024-07-10a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120050512037-06-07U-37732024-07-10a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120050522037-06-07Drug product2024-07-10a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120114372037-06-07Drug product2024-07-10a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120168482037-06-07Drug product2024-07-10a50c72e98297…
2026-08-01 22:54:322026-06N217242-001120424872037-06-07Drug product2024-08-16a50c72e98297…
2026-08-01 22:54:322026-06N217242-001122204092037-06-07Drug product2025-03-07a50c72e98297…
2026-08-01 22:54:322026-06N217242-001122572422037-06-07Drug product2025-04-22a50c72e98297…
2026-08-01 22:54:322026-06N217242-001123109562037-06-07U-37732025-06-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001123109562037-06-07U-42032025-06-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001123369832037-06-07Drug product2025-07-22a50c72e98297…
2026-08-01 22:54:322026-06N217242-001123904532037-06-07Drug product2025-09-12a50c72e98297…
2026-08-01 22:54:322026-06N217242-00198840502037-06-07Drug product2023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-00199077882037-06-07U-42032023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-00199077882037-06-07U-37732023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001111298182037-08-25U-42032023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001111298182037-08-25U-37732023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001117074542041-12-03U-37732023-12-26a50c72e98297…
2026-08-01 22:54:322026-06N217242-001123297512041-12-03U-37732025-07-17a50c72e98297…
2026-08-01 22:54:322026-06N217242-001124537212042-08-19Drug product2025-11-24a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N217242-001NP2026-12-15a50c72e98297…
2026-08-01 22:54:322026-06N217242-001I-9692028-05-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.f9e0b4a9-a227-4947-b00c-41fb18d165892026-06-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 217242
application number: NDA217242
ndc (product): 80610-430

Additional Listing Data#

Finished product
Yes
Brand name base
ZORYVE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0P6C6ZOP5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671682Internal RxNorm lookup
2671684Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9e0b4a9-a227-4947-b00c-41fb18d16589Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcb8b904-8d4f-458b-b954-4eae028a2651Product name220250305
a1a743b6-f2e2-4044-a176-5c60c71ece24Product name120250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7Product name920240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80610-430-60ZORYVE60 g in 1 CANAEROSOL, FOAM606
80610-430-60ZORYVE1 in 1 CARTONAEROSOL, FOAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80610-430-60GM - Gram80610-430dacdebff-4ec6-4a7f-a944-f2df3997466c12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80610-430ZORYVE (ROFLUMILAST) AEROSOL, FOAM [ARCUTIS BIOTHERAPEUTICS, INC.]4Current NDC, 2 package rows20250529_f9e0b4a9-a227-4947-b00c-41fb18d16589.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671682roflumilast 0.3 % Topical FoamPSNf9e0b4a9-a227-4947-b00c-41fb18d165896
2671684ZORYVE 0.3 % Topical FoamPSNf9e0b4a9-a227-4947-b00c-41fb18d165896
2671684roflumilast 3 MG/ML Topical Foam [Zoryve]SBDf9e0b4a9-a227-4947-b00c-41fb18d165896
2671682roflumilast 3 MG/ML Topical FoamSCDf9e0b4a9-a227-4947-b00c-41fb18d165896
2671682roflumilast 0.3 % Topical FoamSYf9e0b4a9-a227-4947-b00c-41fb18d165896
2671684Zoryve 0.3 % Topical FoamSYf9e0b4a9-a227-4947-b00c-41fb18d165896
2671684Zoryve 3 MG/ML Topical FoamSYf9e0b4a9-a227-4947-b00c-41fb18d165896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80610-430-60806100430601 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN1 can2023-12-15NoNoCurrent