Application 212728

Type: NDA
Sponsor: BIOHAVEN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NURTEC ODT	RIMEGEPANT SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 75MG BASE	Yes	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
N212728-001	NURTEC ODT	RIMEGEPANT SULFATE	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		RLD, RS	2020-02-27

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25
N212728-001	8314117	2034-02-27	U-2718	Drug substance, Drug product	2020-03-25
N212728-001	8314117	2034-02-27	U-3142	Drug substance, Drug product	2020-03-25
N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26
N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26

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.

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	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212728-001	NURTEC ODT	EQ 75MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2020-02-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 173 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	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212728-001	8314117	2034-02-27	U-2718	Drug substance, Drug product	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212728-001	8314117	2034-02-27	U-3142	Drug substance, Drug product	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	8314117	2034-02-27	U-2718	Drug substance, Drug product	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	8314117	2034-02-27	U-3142	Drug substance, Drug product	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	8314117	2030-03-09	U-2718	Drug substance, Drug product	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	8314117	2030-03-09	U-3142	Drug substance, Drug product	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	8759372	2033-02-25		Drug substance, Drug product	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	11083724	2039-03-25	U-2718	Drug product	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	11083724	2039-03-25	U-3142	Drug product	2021-08-26	`5bbf6a4d5a75…`

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
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212728-001	NCE	2025-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212728-001	NCE	2025-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212728-001	NCE	2025-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212728-001	NCE	2025-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	I-865	2024-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212728-001	NCE	2025-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	I-865	2024-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212728-001	NCE	2025-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	I-865	2024-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212728-001	NCE	2025-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212728-001	I-865	2024-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212728-001	NCE	2025-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212728-001	I-865	2024-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212728-001	NCE	2025-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212728-001	I-865	2024-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212728-001	NCE	2025-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212728-001	I-865	2024-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212728-001	NCE	2025-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212728-001	I-865	2024-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212728-001	NCE	2025-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212728-001	I-865	2024-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212728-001	NCE	2025-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212728-001	I-865	2024-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212728-001	NCE	2025-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212728-001	I-865	2024-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212728-001	NCE	2025-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212728-001	I-865	2024-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212728-001	NCE	2025-02-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212728-001	I-865	2024-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212728-001	NCE	2025-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212728-001	I-865	2024-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212728-001	NCE	2025-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212728-001	NCE	2025-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212728-001	NCE	2025-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212728-001	NCE	2025-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212728-001	NCE	2025-02-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212728-001	I-865	2024-05-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212728-001	NCE	2025-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212728-001	I-865	2024-05-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212728-001	NCE	2025-02-27	`1c564ffb4f44…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NURTEC ODT	RIMEGEPANT SULFATE	Pfizer Laboratories Div Pfizer Inc	9ef08e09-1098-35cc-e053-2a95a90a3e1d	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212728 application number: NDA212728 ndc (product): 72618-3000
NURTEC ODT	RIMEGEPANT SULFATE	Sportpharm LLC	86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212728 application number: NDA212728

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current
72618-3000	NURTEC ODT	rimegepant sulfate	Biohaven Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85870	SUPPL	2026-05-11
85862	SUPPL	2026-05-11
85470	SUPPL	2026-03-24
85405	SUPPL	2026-03-19
83049	SUPPL	2025-08-05
83040	SUPPL	2025-08-04
81714	SUPPL	2025-03-25
81698	SUPPL	2025-03-24
80570	SUPPL	2025-01-02
80569	SUPPL	2025-01-02
71458	SUPPL	2022-06-27
70762	SUPPL	2022-04-14
70753	SUPPL	2022-04-12
69527	SUPPL	2021-12-10
69519	SUPPL	2021-12-09
67634	SUPPL	2021-06-01
67625	SUPPL	2021-05-28
64303	SUPPL	2020-08-19
64298	SUPPL	2020-08-19
62340	ORIG	2020-03-26
61991	ORIG	2020-02-28
61988	ORIG	2020-02-27