Rinvoq

Product NDC: 0074-2306
11-digit product format: 000742306
Labeler code: 0074
Product ID: 0074-2306_6c4bad0a-5930-4bb7-8509-6a8c6f279082
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Upadacitinib
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA211675
Marketing category: NDA
Marketing start: 2019-08-16
Substance: UPADACITINIB
Active strength: 15 mg/1
Pharmacologic classes: Janus Kinase Inhibitor [EPC], Janus Kinase 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
N211675-001	RINVOQ	UPADACITINIB	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16
N211675-002	RINVOQ	UPADACITINIB	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14
N211675-003	RINVOQ	UPADACITINIB	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16

Orange Book patents#

Current patent rows page 1 of 2 · 97 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211675-001	8962629	2031-01-15	U-3255	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3275	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3341	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3371	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3624	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3945	Drug substance	2019-09-13
N211675-001	8962629	2031-01-15	U-3946	Drug substance	2019-09-13
N211675-001	RE47221	2033-08-16		Drug substance	2019-09-13
N211675-001	10519164	2036-10-17		Drug product	2020-01-29
N211675-001	10597400	2036-10-17	U-3255		2020-04-17
N211675-001	10981923	2036-10-17		Drug substance	2021-05-18
N211675-001	10981924	2036-10-17		Drug product	2021-05-18
N211675-001	10995095	2036-10-17	U-3298		2022-02-10
N211675-001	11186584	2036-10-17		Drug substance	2021-12-17
N211675-001	11198697	2036-10-17		Drug product	2021-12-17
N211675-001	11365198	2036-10-17	U-3275		2022-07-20
N211675-001	11365198	2036-10-17	U-3946		2022-07-20
N211675-001	11512092	2036-10-17	U-3275		2022-12-16
N211675-001	11512092	2036-10-17	U-3371		2022-12-16
N211675-001	11512092	2036-10-17	U-3487		2022-12-16
N211675-001	11512092	2036-10-17	U-3946		2022-12-16
N211675-001	11524964	2036-10-17	U-3371		2023-01-12
N211675-001	11535624	2036-10-17	U-3255		2023-01-26
N211675-001	11535625	2036-10-17	U-3298		2023-01-26
N211675-001	11661425	2036-10-17		Drug substance, Drug product	2023-06-29
N211675-001	11680069	2036-10-17		Drug substance, Drug product	2023-07-20
N211675-001	11718627	2036-10-17		Drug substance, Drug product	2023-08-11
N211675-001	11767326	2036-10-17	U-3298		2023-10-23
N211675-001	11773105	2036-10-17		Drug substance, Drug product	2023-11-02
N211675-001	11773106	2036-10-17	U-3275		2023-11-02
N211675-001	11773106	2036-10-17	U-3371		2023-11-02
N211675-001	11773106	2036-10-17	U-3487		2023-11-02
N211675-001	11773106	2036-10-17	U-3946		2023-11-02
N211675-001	11780847	2036-10-17		Drug product	2023-11-08
N211675-001	11780848	2036-10-17	U-3371		2023-11-08
N211675-001	11787815	2036-10-17		Drug product	2023-11-08
N211675-001	11795175	2036-10-17	U-3255		2023-11-22
N211675-001	11976077	2036-10-17	U-3298		2024-06-05
N211675-001	11993605	2036-10-17	U-3275		2024-06-26
N211675-001	11993605	2036-10-17	U-3946		2024-06-26
N211675-001	11993606	2036-10-17	U-3487		2024-06-26
N211675-001	12077545	2036-10-17		Drug product	2024-09-27
N211675-001	12103933	2036-10-17		Drug product	2024-10-31
N211675-001	12110297	2036-10-17		Drug product	2024-11-05
N211675-001	12110298	2036-10-17		Drug substance, Drug product	2024-11-05
N211675-001	12365689	2036-10-17	U-3945		2025-08-20
N211675-001	12570664	2036-10-17	U-4454		2026-04-08
N211675-001	9951080	2036-10-17		Drug substance, Drug product	2019-09-13
N211675-001	9963459	2036-10-17		Drug product	2019-09-13
N211675-001	11564922	2038-03-09	U-3624		2023-06-15
N211675-001	11564922	2038-03-09	U-4303		2023-06-15
N211675-001	11607411	2038-03-09	U-3341		2023-04-18
N211675-001	11607411	2038-03-09	U-4302		2023-04-18
N211675-002	8962629	2031-01-15	U-3341	Drug substance	2022-02-10
N211675-002	8962629	2031-01-15	U-3624	Drug substance	2022-02-10
N211675-002	RE47221	2033-08-16		Drug substance	2022-02-10
N211675-002	10344036	2036-10-17		Drug product	2022-02-10
N211675-002	10550126	2036-10-17	U-3298		2022-02-10
N211675-002	10730883	2036-10-17		Drug product	2022-02-10
N211675-002	10981923	2036-10-17		Drug substance	2022-02-10
N211675-002	10981924	2036-10-17		Drug product	2022-02-10
N211675-002	11186584	2036-10-17		Drug substance	2022-02-10
N211675-002	11198697	2036-10-17		Drug product	2022-02-10
N211675-002	11535626	2036-10-17	U-3298		2023-01-26
N211675-002	11661425	2036-10-17		Drug substance, Drug product	2023-06-29
N211675-002	11680069	2036-10-17		Drug substance, Drug product	2023-07-20
N211675-002	11718627	2036-10-17		Drug substance, Drug product	2023-08-11
N211675-002	11767326	2036-10-17	U-3298		2023-10-23
N211675-002	11773105	2036-10-17		Drug substance, Drug product	2023-11-02
N211675-002	12077545	2036-10-17		Drug product	2024-09-27
N211675-002	12091415	2036-10-17		Drug product	2024-10-16
N211675-002	12110298	2036-10-17		Drug substance, Drug product	2024-11-05
N211675-002	12116373	2036-10-17		Drug product	2024-11-05
N211675-002	9951080	2036-10-17		Drug substance, Drug product	2022-02-10
N211675-002	11564922	2038-03-09	U-3624		2023-08-11
N211675-002	11564922	2038-03-09	U-4303		2023-08-11
N211675-002	11607411	2038-03-09	U-3341		2023-08-11
N211675-002	11607411	2038-03-09	U-4302		2023-08-11
N211675-003	8962629	2031-01-15	U-3341	Drug substance	2022-04-14
N211675-003	8962629	2031-01-15	U-3624	Drug substance	2022-04-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 14 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211675-001	I-919	2026-05-18
N211675-001	I-946	2027-04-26
N211675-001	NPP	2027-04-26
N211675-001	I-966	2028-04-28
N211675-001	ODE-481	2031-04-26
N211675-001	ODE-538	2032-04-28
N211675-002	I-919	2026-05-18
N211675-002	I-946	2027-04-26
N211675-002	NPP	2027-04-26
N211675-002	ODE-481	2031-04-26
N211675-003	I-919	2026-05-18
N211675-003	I-946	2027-04-26
N211675-003	NPP	2027-04-26
N211675-003	ODE-481	2031-04-26

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 3 · 102 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	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-002	RINVOQ	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2022-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211675-003	RINVOQ	45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211675-001	RINVOQ	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2019-08-16	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 51 · 2,016 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	N211675-001	8962629	2031-01-15	U-3371	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3624	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3946	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3945	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3275	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3255	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	8962629	2031-01-15	U-3341	Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	RE47221	2033-08-16		Drug substance	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10519164	2036-10-17		Drug product	2020-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10597400	2036-10-17	U-3255		2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10981923	2036-10-17		Drug substance	2021-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10981924	2036-10-17		Drug product	2021-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	10995095	2036-10-17	U-3298		2022-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11186584	2036-10-17		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11198697	2036-10-17		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11365198	2036-10-17	U-3946		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11365198	2036-10-17	U-3275		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3946		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3275		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3487		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11512092	2036-10-17	U-3371		2022-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11524964	2036-10-17	U-3371		2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11535624	2036-10-17	U-3255		2023-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11535625	2036-10-17	U-3298		2023-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11661425	2036-10-17		Drug substance, Drug product	2023-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11680069	2036-10-17		Drug substance, Drug product	2023-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11718627	2036-10-17		Drug substance, Drug product	2023-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11767326	2036-10-17	U-3298		2023-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773105	2036-10-17		Drug substance, Drug product	2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3946		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3275		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3487		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11773106	2036-10-17	U-3371		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11780847	2036-10-17		Drug product	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11780848	2036-10-17	U-3371		2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11787815	2036-10-17		Drug product	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11795175	2036-10-17	U-3255		2023-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11976077	2036-10-17	U-3298		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11993605	2036-10-17	U-3275		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	11993605	2036-10-17	U-3946		2024-06-26	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 466 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	N211675-001	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	I-966	2028-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-001	ODE-481	2031-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-002	ODE-481	2031-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	I-919	2026-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	I-946	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	NPP	2027-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211675-003	ODE-481	2031-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-883	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-888	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	I-966	2028-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-001	ODE-481	2031-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-883	2025-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-002	ODE-481	2031-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-886	2025-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-919	2026-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	I-946	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	NPP	2027-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211675-003	ODE-481	2031-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-883	2025-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-886	2025-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-888	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-919	2026-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-946	2027-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	NPP	2027-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	I-966	2028-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211675-001	ODE-481	2031-04-26	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UPADACITINIB	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4RA0KN46E0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2196894	Internal RxNorm lookup
2196900	Internal RxNorm lookup
2590051	Internal RxNorm lookup
2590054	Internal RxNorm lookup
2596957	Internal RxNorm lookup
2596960	Internal RxNorm lookup
2681015	Internal RxNorm lookup
2681019	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
2966aec7-2ef0-923c-d8ff-fe1a957bf095	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed0545f8-aad9-4991-8385-8bf3a9114f4f	Product name	2	20250213
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0074-2306-30	Rinvoq	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		100
0074-2306-70	Rinvoq	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-2306-30	EA - Each	0074-2306	d4f94cd7-6854-4d54-8b59-ff82eeacc738	1	2019-09-05
0074-2306-70	EA - Each	0074-2306	02d5345d-27fc-4022-b8bb-f53b9368e479	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-2306	RINVOQ (UPADACITINIB) TABLET, EXTENDED RELEASE RINVOQ (UPADACITINIB) SOLUTION [ABBVIE INC.]	92	Current NDC, Legacy NDC, 2 package rows	20250501_2966aec7-2ef0-923c-d8ff-fe1a957bf095.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
Rinvoq	UPADACITINIB	AbbVie Inc.	2966aec7-2ef0-923c-d8ff-fe1a957bf095	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211675 application number: NDA211675 ndc (product): 0074-2306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4RA0KN46E0	UPADACITINIB	1310726-60-3	UPADACITINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2196900	RINVOQ 15 MG 24HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590054	RINVOQ 30 MG 24HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596960	RINVOQ 45 MG 24HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681019	RINVOQ LQ 1 MG in 1 mL Oral Solution	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681015	upadacitinib 1 MG in 1 mL Oral Solution	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2196894	upadacitinib 15 MG 24HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590051	upadacitinib 30 MG 24HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596957	upadacitinib 45 MG 24 HR Extended Release Oral Tablet	PSN	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2196900	24 HR upadacitinib 15 MG Extended Release Oral Tablet [Rinvoq]	SBD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590054	24 HR upadacitinib 30 MG Extended Release Oral Tablet [Rinvoq]	SBD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596960	24 HR upadacitinib 45 MG Extended Release Oral Tablet [Rinvoq]	SBD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681019	upadacitinib 1 MG/ML Oral Solution [Rinvoq]	SBD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2196894	24 HR upadacitinib 15 MG Extended Release Oral Tablet	SCD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590051	24 HR upadacitinib 30 MG Extended Release Oral Tablet	SCD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596957	24 HR upadacitinib 45 MG Extended Release Oral Tablet	SCD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681015	upadacitinib 1 MG/ML Oral Solution	SCD	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2196900	24 HR Rinvoq 15 MG Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596960	24 HR Rinvoq 45 MG Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681019	Rinvoq 1 MG per 1 ML Oral Solution	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681019	Rinvoq 1 MG/ML Oral Solution	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2196900	RINVOQ 15 MG 24 HR Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590054	Rinvoq 30 MG 24 HR Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596960	Rinvoq 45 MG 24 HR Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2681015	upadacitinib 1 MG per 1 ML Oral Solution	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2590051	upadacitinib 30 MG 24 HR Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100
2596957	upadacitinib 45 MG 24 HR Extended Release Oral Tablet	SY	2966aec7-2ef0-923c-d8ff-fe1a957bf095	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-2306-30	00074230630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-30)	2019-08-16	0000-00-00	No	No	Current
0074-2306-70	00074230670	14 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-2306-70)	2019-08-16	0000-00-00	Yes	No	Current