FDA.reportPublic FDA data

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215985-001ZORYVEROFLUMILAST0.3%CREAM / TOPICALRLD, RS2022-07-29
N215985-002ZORYVEROFLUMILAST0.15%CREAM / TOPICALRLD, RS2024-07-09
N215985-003ZORYVEROFLUMILAST0.05%CREAM / TOPICALRLD, RS2025-10-04

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215985-001109401422037-06-07Drug product2022-08-19
N215985-001117937962037-06-07Drug product2023-10-24
N215985-001118194962037-06-07U-37482023-11-21
N215985-001119924802037-06-07U-37482024-06-26
N215985-001120050512037-06-07U-37482024-07-09
N215985-001120050522037-06-07Drug product2024-07-09
N215985-001120114372037-06-07Drug product2024-07-09
N215985-001120168482037-06-07Drug product2024-07-09
N215985-001120424872037-06-07Drug product2024-08-21
N215985-001122204092037-06-07Drug product2025-03-07
N215985-001122572422037-06-07Drug product2025-04-22
N215985-001123109562037-06-07U-37482025-06-26
N215985-001123369832037-06-07Drug product2025-07-22
N215985-00198840502037-06-07Drug product2022-08-19
N215985-00199077882037-06-07U-34082022-08-19
N215985-00199077882037-06-07U-37122022-08-19
N215985-001111298182037-08-25U-34082022-08-19
N215985-001111298182037-08-25U-37122022-08-19
N215985-002109401422037-06-07Drug product2024-08-08
N215985-002117937962037-06-07Drug product2024-08-08
N215985-002118194962037-06-07U-39702024-08-08
N215985-002119924802037-06-07U-39702024-08-08
N215985-002120050512037-06-07U-39702024-08-08
N215985-002120050522037-06-07Drug product2024-08-08
N215985-002120114372037-06-07Drug product2024-08-08
N215985-002120168482037-06-07Drug product2024-08-08
N215985-002120424872037-06-07Drug product2024-08-08
N215985-002122204092037-06-07Drug product2025-03-07
N215985-002122572422037-06-07Drug product2025-04-22
N215985-002123109562037-06-07U-39702025-06-26
N215985-002123369832037-06-07Drug product2025-07-22
N215985-00298840502037-06-07Drug product2024-08-08
N215985-00299077882037-06-07U-39702024-08-08
N215985-002111298182037-08-25U-39702024-08-08
N215985-003109401422037-06-07Drug product2025-11-04
N215985-003117937962037-06-07Drug product2025-11-04
N215985-003118194962037-06-07U-43012025-11-04
N215985-003119924802037-06-07U-43012025-11-04
N215985-003120050512037-06-07U-43012025-11-04
N215985-003120050522037-06-07Drug product2025-11-04
N215985-003120114372037-06-07Drug product2025-11-04
N215985-003120168482037-06-07Drug product2025-11-04
N215985-003120424872037-06-07Drug product2025-11-04
N215985-003122204092037-06-07Drug product2025-11-04
N215985-003122572422037-06-07Drug product2025-11-04
N215985-003123109562037-06-07U-43012025-11-04
N215985-003123369832037-06-07Drug product2025-11-04
N215985-00398840502037-06-07Drug product2025-11-04
N215985-00399077882037-06-07U-43012025-11-04
N215985-003111298182037-08-25U-43012025-11-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215985-001NPP2026-10-05
N215985-002NS2027-07-09
N215985-003NS2028-10-04

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 22:54:322026-06N215985-001ZORYVE0.3%CREAM / TOPICALRLD, RS2022-07-29a50c72e98297…
2026-08-01 22:54:322026-06N215985-002ZORYVE0.15%CREAM / TOPICALRLD, RS2024-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-003ZORYVE0.05%CREAM / TOPICALRLD, RS2025-10-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N215985-001109401422037-06-07Drug product2022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-001117937962037-06-07Drug product2023-10-24a50c72e98297…
2026-08-01 22:54:322026-06N215985-001118194962037-06-07U-37482023-11-21a50c72e98297…
2026-08-01 22:54:322026-06N215985-001119924802037-06-07U-37482024-06-26a50c72e98297…
2026-08-01 22:54:322026-06N215985-001120050512037-06-07U-37482024-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-001120050522037-06-07Drug product2024-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-001120114372037-06-07Drug product2024-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-001120168482037-06-07Drug product2024-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-001120424872037-06-07Drug product2024-08-21a50c72e98297…
2026-08-01 22:54:322026-06N215985-001122204092037-06-07Drug product2025-03-07a50c72e98297…
2026-08-01 22:54:322026-06N215985-001122572422037-06-07Drug product2025-04-22a50c72e98297…
2026-08-01 22:54:322026-06N215985-001123109562037-06-07U-37482025-06-26a50c72e98297…
2026-08-01 22:54:322026-06N215985-001123369832037-06-07Drug product2025-07-22a50c72e98297…
2026-08-01 22:54:322026-06N215985-00198840502037-06-07Drug product2022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-00199077882037-06-07U-37122022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-00199077882037-06-07U-34082022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-001111298182037-08-25U-37122022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-001111298182037-08-25U-34082022-08-19a50c72e98297…
2026-08-01 22:54:322026-06N215985-002109401422037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002117937962037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002118194962037-06-07U-39702024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002119924802037-06-07U-39702024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002120050512037-06-07U-39702024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002120050522037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002120114372037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002120168482037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002120424872037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002122204092037-06-07Drug product2025-03-07a50c72e98297…
2026-08-01 22:54:322026-06N215985-002122572422037-06-07Drug product2025-04-22a50c72e98297…
2026-08-01 22:54:322026-06N215985-002123109562037-06-07U-39702025-06-26a50c72e98297…
2026-08-01 22:54:322026-06N215985-002123369832037-06-07Drug product2025-07-22a50c72e98297…
2026-08-01 22:54:322026-06N215985-00298840502037-06-07Drug product2024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-00299077882037-06-07U-39702024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-002111298182037-08-25U-39702024-08-08a50c72e98297…
2026-08-01 22:54:322026-06N215985-003109401422037-06-07Drug product2025-11-04a50c72e98297…
2026-08-01 22:54:322026-06N215985-003117937962037-06-07Drug product2025-11-04a50c72e98297…
2026-08-01 22:54:322026-06N215985-003118194962037-06-07U-43012025-11-04a50c72e98297…
2026-08-01 22:54:322026-06N215985-003119924802037-06-07U-43012025-11-04a50c72e98297…
2026-08-01 22:54:322026-06N215985-003120050512037-06-07U-43012025-11-04a50c72e98297…
2026-08-01 22:54:322026-06N215985-003120050522037-06-07Drug product2025-11-04a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N215985-001NPP2026-10-05a50c72e98297…
2026-08-01 22:54:322026-06N215985-002NS2027-07-09a50c72e98297…
2026-08-01 22:54:322026-06N215985-003NS2028-10-04a50c72e98297…

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.ec1bb0d1-f38a-4080-831a-68791d1d1fdb2026-07-02Adverse reactionsExact identifier
application applno (NDA): 215985
application number: NDA215985
ndc (product): 80610-115

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST1.5 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2608534Internal RxNorm lookup
2608539Internal RxNorm lookup
2687710Internal RxNorm lookup
2687712Internal RxNorm lookup
2725121Internal RxNorm lookup
2725123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec1bb0d1-f38a-4080-831a-68791d1d1fdbAvailable 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
80610-115-05ZORYVE5 g in 1 TUBECREAM512
80610-115-60ZORYVE1 in 1 CARTONCREAM112
80610-115-60ZORYVE60 g in 1 TUBECREAM6012
80610-115-96ZORYVE6 in 1 CARTONCREAM612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80610-115-60GM - Gram80610-115de07469a-dc91-4cd4-ae64-6bd0b3f8eb0512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80610-115ZORYVE (ROFLUMILAST) CREAM [ARCUTIS BIOTHERAPEUTICS, INC.]9Current NDC, 4 package rows20240815_ec1bb0d1-f38a-4080-831a-68791d1d1fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725121roflumilast 0.05 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687710roflumilast 0.15 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608534roflumilast 0.3 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2725123ZORYVE 0.05 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687712ZORYVE 0.15 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608539ZORYVE 0.3 % Topical CreamPSNec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2725123roflumilast 0.5 MG/ML Topical Cream [Zoryve]SBDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687712roflumilast 1.5 MG/ML Topical Cream [Zoryve]SBDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608539roflumilast 3 MG/ML Topical Cream [Zoryve]SBDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2725121roflumilast 0.5 MG/ML Topical CreamSCDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687710roflumilast 1.5 MG/ML Topical CreamSCDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608534roflumilast 3 MG/ML Topical CreamSCDec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2725121roflumilast 0.05 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687710roflumilast 0.15 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608534roflumilast 0.3 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2725123Zoryve 0.05 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687712Zoryve 0.15 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608539Zoryve 0.3 % Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2687712Zoryve 1.5 MG/ML Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12
2608539Zoryve 3 MG/ML Topical CreamSYec1bb0d1-f38a-4080-831a-68791d1d1fdb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80610-115-05806100115055 g in 1 TUBE5 gHistorical
80610-115-60806100115601 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE1 tube2024-07-09NoNoCurrent
80610-115-96806100115966 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05) 6 tube2024-07-09NoNoCurrent