UBRELVY

Product NDC: 0023-6501
11-digit product format: 000236501
Labeler code: 0023
Product ID: 0023-6501_07fd3ef4-ef45-4b86-a6ab-75457fbe68ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ubrogepant
Dosage form: TABLET
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA211765
Marketing category: NDA
Marketing start: 2019-12-23
Substance: UBROGEPANT
Active strength: 100 mg/1
Pharmacologic classes: Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211765-001	UBRELVY	UBROGEPANT	50MG	TABLET / ORAL		RLD	2019-12-23
N211765-002	UBRELVY	UBROGEPANT	100MG	TABLET / ORAL		RLD, RS	2019-12-23

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21
N211765-001	9833448	2031-11-10	U-2718		2020-01-21
N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21
N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21
N211765-001	10117836	2035-01-30		Drug product	2020-01-21
N211765-001	11925709	2035-01-30		Drug product	2024-04-10
N211765-001	12168004	2035-01-30		Drug product	2025-01-15
N211765-001	12220408	2035-01-30		Drug product	2025-03-12
N211765-001	12310953	2035-01-30		Drug product	2025-06-25
N211765-001	12458632	2035-01-30		Drug product	2025-11-04
N211765-001	12458633	2035-01-30		Drug product	2025-11-04
N211765-001	11717515	2041-12-22	U-3677		2023-09-07
N211765-001	11857542	2041-12-22	U-3786		2024-01-31
N211765-001	12194030	2041-12-22	U-4121		2025-02-11
N211765-001	12194030	2041-12-22	U-4122		2025-02-11
N211765-001	12329750	2041-12-22	U-4213		2025-07-16
N211765-002	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21
N211765-002	9833448	2031-11-10	U-2718		2020-01-21
N211765-002	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21
N211765-002	8912210	2033-12-23		Drug substance, Drug product	2020-01-21
N211765-002	10117836	2035-01-30		Drug product	2020-01-21
N211765-002	11925709	2035-01-30		Drug product	2024-04-10
N211765-002	12168004	2035-01-30		Drug product	2025-01-15
N211765-002	12220408	2035-01-30		Drug product	2025-03-12
N211765-002	12310953	2035-01-30		Drug product	2025-06-25
N211765-002	12458632	2035-01-30		Drug product	2025-11-04
N211765-002	12458633	2035-01-30		Drug product	2025-11-04
N211765-002	12070450	2041-12-22	U-3992		2024-09-25

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 · 74 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	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 503 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	N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	9833448	2031-11-10	U-2718		2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	10117836	2035-01-30		Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	11925709	2035-01-30		Drug product	2024-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12168004	2035-01-30		Drug product	2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12220408	2035-01-30		Drug product	2025-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12310953	2035-01-30		Drug product	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12458632	2035-01-30		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12458633	2035-01-30		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	11717515	2041-12-22	U-3677		2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	11857542	2041-12-22	U-3786		2024-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12194030	2041-12-22	U-4121		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12194030	2041-12-22	U-4122		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-001	12329750	2041-12-22	U-4213		2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	9833448	2031-11-10	U-2718		2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	10117836	2035-01-30		Drug product	2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	11925709	2035-01-30		Drug product	2024-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12168004	2035-01-30		Drug product	2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12220408	2035-01-30		Drug product	2025-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12310953	2035-01-30		Drug product	2025-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12458632	2035-01-30		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12458633	2035-01-30		Drug product	2025-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	12070450	2041-12-22	U-3992		2024-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	9833448	2031-11-10	U-2718		2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	10117836	2035-01-30		Drug product	2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	11925709	2035-01-30		Drug product	2024-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	12168004	2035-01-30		Drug product	2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	12220408	2035-01-30		Drug product	2025-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	12310953	2035-01-30		Drug product	2025-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	12458632	2035-01-30		Drug product	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	12458633	2035-01-30		Drug product	2025-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	11717515	2041-12-22	U-3677		2023-09-07	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-001	NCE	2024-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-002	NCE	2024-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-001	NCE	2024-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-002	NCE	2024-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-001	NCE	2024-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-002	NCE	2024-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-001	NCE	2024-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-002	NCE	2024-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211765-001	NCE	2024-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211765-002	NCE	2024-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-001	NCE	2024-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-002	NCE	2024-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-001	NCE	2024-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-002	NCE	2024-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-001	NCE	2024-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-002	NCE	2024-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211765-001	NCE	2024-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211765-002	NCE	2024-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-001	NCE	2024-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-002	NCE	2024-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211765-001	NCE	2024-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211765-002	NCE	2024-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211765-001	NCE	2024-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211765-002	NCE	2024-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211765-001	NCE	2024-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211765-002	NCE	2024-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211765-001	NCE	2024-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211765-002	NCE	2024-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211765-001	NCE	2024-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211765-002	NCE	2024-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211765-001	NCE	2024-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N211765-002	NCE	2024-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211765-001	NCE	2024-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N211765-002	NCE	2024-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211765-001	NCE	2024-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N211765-002	NCE	2024-12-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211765-001	NCE	2024-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211765-002	NCE	2024-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211765-001	NCE	2024-12-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211765-002	NCE	2024-12-23	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: UBRELVY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UBROGEPANT	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AD0O8X2QJR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2268221	Internal RxNorm lookup
2268227	Internal RxNorm lookup
2268229	Internal RxNorm lookup
2268231	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
fd9f9458-fd96-4688-be3f-f77b3d1af6ab	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
974ec6d6-bdb6-4dfa-b124-6fbf6e8df619	Product name	1	20200605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0023-6501-01	UBRELVY	1 in 1 BOX	TABLET	1	27
0023-6501-01	UBRELVY	1 in 1 PACKET	TABLET	1	27
0023-6501-02	UBRELVY	1 in 1 PACKET	TABLET	1	27
0023-6501-10	UBRELVY	10 in 1 BOX	TABLET	10	27
0023-6501-16	UBRELVY	16 in 1 BOX	TABLET	16	27
0023-6501-30	UBRELVY	30 in 1 BOX	TABLET	30	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-6501-01	EA - Each	0023-6501	d2085d82-4a53-4680-b0ee-017cf674c932	1	2024-10-04
0023-6501-02	EA - Each	0023-6501	1f5a198e-c38f-4579-b874-cf3e179a8d7d	1	2020-02-13
0023-6501-10	EA - Each	0023-6501	1097cd70-1b67-4562-9c4f-3fd3989375fa	1	2020-02-13
0023-6501-16	EA - Each	0023-6501	2d54611f-1ac0-4eb3-93fa-a4f070683bc9	1	2022-02-07
0023-6501-30	EA - Each	0023-6501	ddf2e9e5-484b-4af3-92e2-4bb55c3bea7f	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-6501	UBRELVY (UBROGEPANT) TABLET [ALLERGAN, INC.]	26	Current NDC, Legacy NDC, 6 package rows	20250328_fd9f9458-fd96-4688-be3f-f77b3d1af6ab.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
UBRELVY	UBROGEPANT	Allergan, Inc.	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211765 application number: NDA211765 ndc (product): 0023-6501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AD0O8X2QJR	UBROGEPANT	1374248-77-7	UBROGEPANT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2268227	ubrelvy 100 MG Oral Tablet	PSN	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268231	ubrelvy 50 MG Oral Tablet	PSN	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268221	ubrogepant 100 MG Oral Tablet	PSN	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268229	ubrogepant 50 MG Oral Tablet	PSN	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268227	ubrogepant 100 MG Oral Tablet [Ubrelvy]	SBD	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268231	ubrogepant 50 MG Oral Tablet [Ubrelvy]	SBD	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268221	ubrogepant 100 MG Oral Tablet	SCD	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268229	ubrogepant 50 MG Oral Tablet	SCD	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268227	Ubrelvy 100 MG Oral Tablet	SY	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27
2268231	Ubrelvy 50 MG Oral Tablet	SY	fd9f9458-fd96-4688-be3f-f77b3d1af6ab	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-6501-01	00023650101	1 PACKET in 1 BOX (0023-6501-01) / 1 TABLET in 1 PACKET	1 packet	2019-12-23		Yes	No	Current
0023-6501-02	00023650102	1 in 1 PACKET						Historical
0023-6501-10	00023650110	10 PACKET in 1 BOX (0023-6501-10) / 1 TABLET in 1 PACKET (0023-6501-02)	10 packet	2019-12-23	0000-00-00	No	No	Current
0023-6501-16	00023650116	16 PACKET in 1 BOX (0023-6501-16) / 1 TABLET in 1 PACKET (0023-6501-02)	16 packet	2019-12-23	0000-00-00	No	No	Current
0023-6501-30	00023650130	30 PACKET in 1 BOX (0023-6501-30) / 1 TABLET in 1 PACKET (0023-6501-02)	30 packet	2019-12-23	0000-00-00	No	No	Current