OPZELURA

Product NDC: 50881-007
Requested package NDC: 50881-007-07
11-digit product format: 508810007
Labeler code: 50881
Product ID: 50881-007_a32bcaac-6cd8-41be-8686-3e10268e0539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ruxolitinib
Dosage form: CREAM
Route: TOPICAL
Labeler: Incyte Corporation
Application: NDA215309
Marketing category: NDA
Marketing start: 2021-09-21
Substance: RUXOLITINIB PHOSPHATE
Active strength: 15 mg/g
Pharmacologic classes: Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215309-001	OPZELURA	RUXOLITINIB PHOSPHATE	EQ 1.5% BASE	CREAM / TOPICAL		RLD, RS	2021-09-21

Orange Book patents#

Current patent rows page 1 of 1 · 39 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215309-001	10639310	2026-12-12	U-3229		2021-10-20
N215309-001	9079912	2026-12-12	U-3229		2021-10-20
N215309-001	9079912	2026-12-12	U-3404		2021-10-20
N215309-001	9974790	2026-12-12	U-3229		2021-10-20
N215309-001	9974790	2026-12-12	U-3404		2021-10-20
N215309-001	10639310*PED	2027-06-12		Pediatric extension
N215309-001	9079912*PED	2027-06-12		Pediatric extension
N215309-001	9974790*PED	2027-06-12		Pediatric extension
N215309-001	7598257	2027-12-24		Drug substance, Drug product	2021-10-20
N215309-001	8415362	2027-12-24		Drug substance, Drug product	2021-10-20
N215309-001	10610530	2028-06-12	U-3229		2021-10-20
N215309-001	10610530	2028-06-12	U-3404		2021-10-20
N215309-001	8722693	2028-06-12		Drug substance, Drug product	2021-10-20
N215309-001	8822481	2028-06-12	U-3229		2021-10-20
N215309-001	8822481	2028-06-12	U-3404		2021-10-20
N215309-001	7598257*PED	2028-06-24		Pediatric extension
N215309-001	8415362*PED	2028-06-24		Pediatric extension
N215309-001	10610530*PED	2028-12-12		Pediatric extension
N215309-001	8722693*PED	2028-12-12		Pediatric extension
N215309-001	8822481*PED	2028-12-12		Pediatric extension
N215309-001	10758543	2031-05-20		Drug product	2021-10-20
N215309-001	10869870	2031-05-20	U-3229		2021-10-20
N215309-001	10869870	2031-05-20	U-3404		2021-10-20
N215309-001	11219624	2031-05-20	U-3229	Drug product	2022-02-08
N215309-001	11571425	2031-05-20		Drug product	2023-02-28
N215309-001	11590136	2031-05-20	U-3229		2023-03-28
N215309-001	11590136	2031-05-20	U-3404		2023-03-28
N215309-001	12226419	2031-05-20		Drug product	2025-03-17
N215309-001	12544381	2031-05-20		Drug product	2026-03-03
N215309-001	12564593	2031-05-20		Drug product	2026-03-24
N215309-001	10758543*PED	2031-11-20		Pediatric extension
N215309-001	10869870*PED	2031-11-20		Pediatric extension
N215309-001	11219624*PED	2031-11-20		Pediatric extension
N215309-001	11590138	2040-06-10	U-3551		2023-03-28
N215309-001	12233067	2040-07-28	U-4151		2025-03-17
N215309-001	11510923	2040-09-04	U-3505		2022-12-16
N215309-001	11590137	2040-09-04	U-3505		2023-03-28
N215309-001	12589096	2040-09-04	U-3505		2026-04-27
N215309-001	11602536	2041-05-05	U-3550		2023-03-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215309-001	I-896	2025-07-18
N215309-001	PED	2026-01-18
N215309-001	NPP	2028-09-18

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215309-001	OPZELURA	EQ 1.5% BASE	CREAM / TOPICAL	RLD, RS	2021-09-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 933 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	N215309-001	10639310	2026-12-12	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9079912	2026-12-12	U-3404		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9079912	2026-12-12	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9974790	2026-12-12	U-3404		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9974790	2026-12-12	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10639310*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9079912*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	9974790*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	7598257	2027-12-24		Drug substance, Drug product	2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8415362	2027-12-24		Drug substance, Drug product	2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10610530	2028-06-12	U-3404		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10610530	2028-06-12	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8722693	2028-06-12		Drug substance, Drug product	2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8822481	2028-06-12	U-3404		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8822481	2028-06-12	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	7598257*PED	2028-06-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8415362*PED	2028-06-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10610530*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8722693*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	8822481*PED	2028-12-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10758543	2031-05-20		Drug product	2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10869870	2031-05-20	U-3404		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10869870	2031-05-20	U-3229		2021-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11219624	2031-05-20	U-3229	Drug product	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11571425	2031-05-20		Drug product	2023-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11590136	2031-05-20	U-3229		2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11590136	2031-05-20	U-3404		2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	12226419	2031-05-20		Drug product	2025-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10758543*PED	2031-11-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	10869870*PED	2031-11-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11219624*PED	2031-11-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11590138	2040-06-10	U-3551		2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	12233067	2040-07-28	U-4151		2025-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11510923	2040-09-04	U-3505		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11590137	2040-09-04	U-3505		2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	11602536	2041-05-05	U-3550		2023-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	10639310	2026-12-12	U-3229		2021-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	9079912	2026-12-12	U-3404		2021-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	9079912	2026-12-12	U-3229		2021-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	9974790	2026-12-12	U-3404		2021-10-20	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 107 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	N215309-001	I-896	2025-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	PED	2026-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215309-001	NPP	2028-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	NP	2024-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	PED	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	I-896	2025-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	PED	2026-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215309-001	NPP	2028-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215309-001	NP	2024-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	PED	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	I-896	2025-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215309-001	PED	2026-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	NP	2024-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	PED	2025-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	I-896	2025-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215309-001	PED	2026-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	NP	2024-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	PED	2025-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	I-896	2025-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215309-001	PED	2026-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	NP	2024-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	PED	2025-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	I-896	2025-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215309-001	PED	2026-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	NP	2024-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	PED	2025-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	I-896	2025-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215309-001	PED	2026-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	NP	2024-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	PED	2025-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	I-896	2025-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215309-001	PED	2026-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	NP	2024-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	PED	2025-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	I-896	2025-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215309-001	PED	2026-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215309-001	NP	2024-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215309-001	PED	2025-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215309-001	I-896	2025-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215309-001	PED	2026-01-18	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RUXOLITINIB PHOSPHATE	15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
436LRU32H5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2570752	Internal RxNorm lookup
2570757	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
24da5509-6631-4795-9d42-273faecd08e7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
54477ffc-bf5d-4583-bcf6-d041bdba36f1	Product name	1	20220316
95a946d8-a784-4eb7-bff4-2194e4331c6f	Product name	1	20190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50881-007-04	OPZELURA	1 in 1 CARTON	CREAM	1	13
50881-007-04	OPZELURA	5 g in 1 TUBE	CREAM	5	13
50881-007-05	OPZELURA	60 g in 1 TUBE	CREAM	60	13
50881-007-05	OPZELURA	1 in 1 CARTON	CREAM	1	13
50881-007-07	OPZELURA	100 g in 1 TUBE	CREAM	100	13
50881-007-07	OPZELURA	1 in 1 CARTON	CREAM	1	13
50881-007-14	OPZELURA	1 in 1 CARTON	CREAM	1	13
50881-007-14	OPZELURA	3 g in 1 TUBE	CREAM	3	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50881-007-05	GM - Gram	50881-007	2d0d4914-dbdb-4bf7-98d1-97089f1d7143	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50881-007	OPZELURA (RUXOLITINIB) CREAM [INCYTE CORPORATION]	11	Current NDC, Legacy NDC, 8 package rows	20240831_24da5509-6631-4795-9d42-273faecd08e7.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPZELURA	RUXOLITINIB	Incyte Corporation	24da5509-6631-4795-9d42-273faecd08e7	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215309 application number: NDA215309 ndc (package): 50881-007-07 ndc (product): 50881-007 ndc11 (package): 50881000707

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
436LRU32H5	RUXOLITINIB PHOSPHATE	1092939-17-7	RUXOLITINIB PHOSPHATE
82S8X8XX8H	RUXOLITINIB	941678-49-5	ruxolitinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2570757	Opzelura 1.5 % Topical Cream	PSN	24da5509-6631-4795-9d42-273faecd08e7	13
2570752	ruxolitinib 15 MG/ML Topical Cream	PSN	24da5509-6631-4795-9d42-273faecd08e7	13
2570757	ruxolitinib 15 MG/ML Topical Cream [Opzelura]	SBD	24da5509-6631-4795-9d42-273faecd08e7	13
2570752	ruxolitinib 15 MG/ML Topical Cream	SCD	24da5509-6631-4795-9d42-273faecd08e7	13
2570757	Opzelura 1.5 % Topical Cream	SY	24da5509-6631-4795-9d42-273faecd08e7	13
2570757	Opzelura 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream	SY	24da5509-6631-4795-9d42-273faecd08e7	13
2570757	Opzelura 15 MG/ML Topical Cream	SY	24da5509-6631-4795-9d42-273faecd08e7	13
2570752	ruxolitinib 1.5 % Topical Cream	SY	24da5509-6631-4795-9d42-273faecd08e7	13
2570752	ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical Cream	SY	24da5509-6631-4795-9d42-273faecd08e7	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50881-007-07	50881000707	1 TUBE in 1 CARTON (50881-007-07) / 100 g in 1 TUBE	1 tube	2022-04-15	0000-00-00	No	No	Current