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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215985-001	ZORYVE	ROFLUMILAST	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29
N215985-002	ZORYVE	ROFLUMILAST	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09
N215985-003	ZORYVE	ROFLUMILAST	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215985-001	10940142	2037-06-07		Drug product	2022-08-19
N215985-001	11793796	2037-06-07		Drug product	2023-10-24
N215985-001	11819496	2037-06-07	U-3748		2023-11-21
N215985-001	11992480	2037-06-07	U-3748		2024-06-26
N215985-001	12005051	2037-06-07	U-3748		2024-07-09
N215985-001	12005052	2037-06-07		Drug product	2024-07-09
N215985-001	12011437	2037-06-07		Drug product	2024-07-09
N215985-001	12016848	2037-06-07		Drug product	2024-07-09
N215985-001	12042487	2037-06-07		Drug product	2024-08-21
N215985-001	12220409	2037-06-07		Drug product	2025-03-07
N215985-001	12257242	2037-06-07		Drug product	2025-04-22
N215985-001	12310956	2037-06-07	U-3748		2025-06-26
N215985-001	12336983	2037-06-07		Drug product	2025-07-22
N215985-001	9884050	2037-06-07		Drug product	2022-08-19
N215985-001	9907788	2037-06-07	U-3408		2022-08-19
N215985-001	9907788	2037-06-07	U-3712		2022-08-19
N215985-001	11129818	2037-08-25	U-3408		2022-08-19
N215985-001	11129818	2037-08-25	U-3712		2022-08-19
N215985-002	10940142	2037-06-07		Drug product	2024-08-08
N215985-002	11793796	2037-06-07		Drug product	2024-08-08
N215985-002	11819496	2037-06-07	U-3970		2024-08-08
N215985-002	11992480	2037-06-07	U-3970		2024-08-08
N215985-002	12005051	2037-06-07	U-3970		2024-08-08
N215985-002	12005052	2037-06-07		Drug product	2024-08-08
N215985-002	12011437	2037-06-07		Drug product	2024-08-08
N215985-002	12016848	2037-06-07		Drug product	2024-08-08
N215985-002	12042487	2037-06-07		Drug product	2024-08-08
N215985-002	12220409	2037-06-07		Drug product	2025-03-07
N215985-002	12257242	2037-06-07		Drug product	2025-04-22
N215985-002	12310956	2037-06-07	U-3970		2025-06-26
N215985-002	12336983	2037-06-07		Drug product	2025-07-22
N215985-002	9884050	2037-06-07		Drug product	2024-08-08
N215985-002	9907788	2037-06-07	U-3970		2024-08-08
N215985-002	11129818	2037-08-25	U-3970		2024-08-08
N215985-003	10940142	2037-06-07		Drug product	2025-11-04
N215985-003	11793796	2037-06-07		Drug product	2025-11-04
N215985-003	11819496	2037-06-07	U-4301		2025-11-04
N215985-003	11992480	2037-06-07	U-4301		2025-11-04
N215985-003	12005051	2037-06-07	U-4301		2025-11-04
N215985-003	12005052	2037-06-07		Drug product	2025-11-04
N215985-003	12011437	2037-06-07		Drug product	2025-11-04
N215985-003	12016848	2037-06-07		Drug product	2025-11-04
N215985-003	12042487	2037-06-07		Drug product	2025-11-04
N215985-003	12220409	2037-06-07		Drug product	2025-11-04
N215985-003	12257242	2037-06-07		Drug product	2025-11-04
N215985-003	12310956	2037-06-07	U-4301		2025-11-04
N215985-003	12336983	2037-06-07		Drug product	2025-11-04
N215985-003	9884050	2037-06-07		Drug product	2025-11-04
N215985-003	9907788	2037-06-07	U-4301		2025-11-04
N215985-003	11129818	2037-08-25	U-4301		2025-11-04

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215985-001	NPP	2026-10-05
N215985-002	NS	2027-07-09
N215985-003	NS	2028-10-04

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	ZORYVE	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-003	ZORYVE	0.05%	CREAM / TOPICAL	RLD, RS	2025-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-002	ZORYVE	0.15%	CREAM / TOPICAL	RLD, RS	2024-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215985-001	ZORYVE	0.3%	CREAM / TOPICAL	RLD, RS	2022-07-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 473 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215985-001	10940142	2037-06-07		Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11793796	2037-06-07		Drug product	2023-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11819496	2037-06-07	U-3748		2023-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11992480	2037-06-07	U-3748		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12005051	2037-06-07	U-3748		2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12005052	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12011437	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12016848	2037-06-07		Drug product	2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12042487	2037-06-07		Drug product	2024-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12220409	2037-06-07		Drug product	2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12257242	2037-06-07		Drug product	2025-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12310956	2037-06-07	U-3748		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	12336983	2037-06-07		Drug product	2025-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9884050	2037-06-07		Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9907788	2037-06-07	U-3712		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	9907788	2037-06-07	U-3408		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11129818	2037-08-25	U-3712		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-001	11129818	2037-08-25	U-3408		2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	10940142	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11793796	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11819496	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11992480	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12005051	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12005052	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12011437	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12016848	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12042487	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12220409	2037-06-07		Drug product	2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12257242	2037-06-07		Drug product	2025-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12310956	2037-06-07	U-3970		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	12336983	2037-06-07		Drug product	2025-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	9884050	2037-06-07		Drug product	2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	9907788	2037-06-07	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	11129818	2037-08-25	U-3970		2024-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	10940142	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11793796	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11819496	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	11992480	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	12005051	2037-06-07	U-4301		2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	12005052	2037-06-07		Drug product	2025-11-04	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215985-001	NPP	2026-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-002	NS	2027-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215985-003	NS	2028-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	NP	2025-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-001	NPP	2026-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-002	NS	2027-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215985-003	NS	2028-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215985-001	NP	2025-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-001	NPP	2026-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215985-002	NS	2027-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	NP	2025-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-001	NPP	2026-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215985-002	NS	2027-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	NP	2025-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-001	NPP	2026-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215985-002	NS	2027-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	NP	2025-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-001	NPP	2026-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215985-002	NS	2027-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	NP	2025-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-001	NPP	2026-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215985-002	NS	2027-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	NP	2025-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-001	NPP	2026-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215985-002	NS	2027-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	NP	2025-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-001	NPP	2026-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215985-002	NS	2027-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215985-001	NP	2025-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-001	NPP	2026-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215985-002	NS	2027-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	NP	2025-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-001	NPP	2026-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215985-002	NS	2027-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	NP	2025-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215985-001	NPP	2026-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	NP	2025-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215985-001	NPP	2026-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215985-001	NP	2025-07-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215985-001	NPP	2026-10-05	`8072bd15b7f6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	2026-07-02	Adverse reactions	Exact 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
Ingredient	Strength
ROFLUMILAST	1.5 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 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
ec1bb0d1-f38a-4080-831a-68791d1d1fdb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dcb8b904-8d4f-458b-b954-4eae028a2651	Product name	2	20250305
a1a743b6-f2e2-4044-a176-5c60c71ece24	Product name	1	20250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7	Product name	9	20240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80610-115-05	ZORYVE	5 g in 1 TUBE	CREAM	5	12
80610-115-60	ZORYVE	1 in 1 CARTON	CREAM	1	12
80610-115-60	ZORYVE	60 g in 1 TUBE	CREAM	60	12
80610-115-96	ZORYVE	6 in 1 CARTON	CREAM	6	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80610-115-60	GM - Gram	80610-115	de07469a-dc91-4cd4-ae64-6bd0b3f8eb05	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80610-115	ZORYVE (ROFLUMILAST) CREAM [ARCUTIS BIOTHERAPEUTICS, INC.]	9	Current NDC, 4 package rows	20240815_ec1bb0d1-f38a-4080-831a-68791d1d1fdb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0P6C6ZOP5U	ROFLUMILAST	162401-32-3	ROFLUMILAST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2725121	roflumilast 0.05 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687710	roflumilast 0.15 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608534	roflumilast 0.3 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2725123	ZORYVE 0.05 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687712	ZORYVE 0.15 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608539	ZORYVE 0.3 % Topical Cream	PSN	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2725123	roflumilast 0.5 MG/ML Topical Cream [Zoryve]	SBD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687712	roflumilast 1.5 MG/ML Topical Cream [Zoryve]	SBD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608539	roflumilast 3 MG/ML Topical Cream [Zoryve]	SBD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2725121	roflumilast 0.5 MG/ML Topical Cream	SCD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687710	roflumilast 1.5 MG/ML Topical Cream	SCD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608534	roflumilast 3 MG/ML Topical Cream	SCD	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2725121	roflumilast 0.05 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687710	roflumilast 0.15 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608534	roflumilast 0.3 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2725123	Zoryve 0.05 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687712	Zoryve 0.15 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608539	Zoryve 0.3 % Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2687712	Zoryve 1.5 MG/ML Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12
2608539	Zoryve 3 MG/ML Topical Cream	SY	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80610-115-05	80610011505	5 g in 1 TUBE	5 g				Historical
80610-115-60	80610011560	1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE	1 tube	2024-07-09	No	No	Current
80610-115-96	80610011596	6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05)	6 tube	2024-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZORYVE	Arcutis Biotherapeutics, Inc. \| DPT Laboratories, Ltd	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	13