Home NDC 80610-430 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 80610-430-93 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 80610-430-93 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 80610-430-93 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 80610-430-93 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80610-430-60 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217242-001 ZORYVE ROFLUMILAST 0.3% FOAM / TOPICAL RLD, RS 2023-12-15
Orange Book patents# Current patent rows page 1 of 1 · 26 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217242-001 NP 2026-12-15 N217242-001 I-969 2028-05-22
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217242-001 ZORYVE 0.3% FOAM / TOPICAL RLD, RS 2023-12-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 272 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217242-001 10940142 2037-06-07 Drug product 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11793796 2037-06-07 Drug product 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11819496 2037-06-07 U-4203 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11819496 2037-06-07 U-3773 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11992480 2037-06-07 U-4203 2024-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11992480 2037-06-07 U-3773 2024-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12005051 2037-06-07 U-4203 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12005051 2037-06-07 U-3773 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12005052 2037-06-07 Drug product 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12011437 2037-06-07 Drug product 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12016848 2037-06-07 Drug product 2024-07-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12042487 2037-06-07 Drug product 2024-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12220409 2037-06-07 Drug product 2025-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12257242 2037-06-07 Drug product 2025-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12310956 2037-06-07 U-3773 2025-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12310956 2037-06-07 U-4203 2025-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12336983 2037-06-07 Drug product 2025-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12390453 2037-06-07 Drug product 2025-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 9884050 2037-06-07 Drug product 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 9907788 2037-06-07 U-4203 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 9907788 2037-06-07 U-3773 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11129818 2037-08-25 U-4203 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11129818 2037-08-25 U-3773 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 11707454 2041-12-03 U-3773 2023-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12329751 2041-12-03 U-3773 2025-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217242-001 12453721 2042-08-19 Drug product 2025-11-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217242-001 10940142 2037-06-07 Drug product 2023-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 11793796 2037-06-07 Drug product 2023-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 11819496 2037-06-07 U-4203 2023-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 11819496 2037-06-07 U-3773 2023-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 11992480 2037-06-07 U-4203 2024-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 11992480 2037-06-07 U-3773 2024-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12005051 2037-06-07 U-4203 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12005051 2037-06-07 U-3773 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12005052 2037-06-07 Drug product 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12011437 2037-06-07 Drug product 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12016848 2037-06-07 Drug product 2024-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12042487 2037-06-07 Drug product 2024-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12220409 2037-06-07 Drug product 2025-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217242-001 12257242 2037-06-07 Drug product 2025-04-22 011fe1cb6892…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ZORYVE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROFLUMILAST 3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0P6C6ZOP5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671682 Internal RxNorm lookup 2671684 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80610-430-60 ZORYVE 60 g in 1 CAN AEROSOL, FOAM 60 6 80610-430-60 ZORYVE 1 in 1 CARTON AEROSOL, FOAM 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80610-430 ZORYVE (ROFLUMILAST) AEROSOL, FOAM [ARCUTIS BIOTHERAPEUTICS, INC.] 4 Current NDC, 2 package rows 20250529_f9e0b4a9-a227-4947-b00c-41fb18d16589.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80610-430-60 80610043060 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN 1 can 2023-12-15 No No Current