NURTEC ODT

Product NDC: 72618-3001
Requested package NDC: 72618-3001-4
11-digit product format: 726183001
Labeler code: 72618
Product ID: 72618-3001_8ca7820c-5f58-4958-998b-9e18481d7dc0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rimegepant sulfate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA212728
Marketing category: NDA
Marketing start: 2020-03-05
Substance: RIMEGEPANT SULFATE
Active strength: 75 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: 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIMEGEPANT SULFATE	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1383NM3Q0H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2282313	Internal RxNorm lookup
2282320	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
9ef08e09-1098-35cc-e053-2a95a90a3e1d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8be78f19-acf0-4ff5-9835-5b77f9de5644	Product name	1	20200626

FDA-Initiated Inactive NDC Indexing#

Related label table
Related label
These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72618-3001-1	NURTEC ODT	2 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	2	31
72618-3001-1	NURTEC ODT	1 in 1 DOSE PACK	TABLET, ORALLY DISINTEGRATING	1	31
72618-3001-2	NURTEC ODT	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72618-3001	NURTEC ODT (RIMEGEPANT SULFATE) TABLET, ORALLY DISINTEGRATING [PFIZER LABORATORIES DIV PFIZER INC]	25	Current NDC, 3 package rows	20250406_9ef08e09-1098-35cc-e053-2a95a90a3e1d.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 · 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 (package): 72618-3001-4 ndc (product): 72618-3001 ndc11 (package): 72618300104
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1383NM3Q0H	RIMEGEPANT SULFATE	1374024-48-2	RIMEGEPANT SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2282320	Nurtec ODT 75 MG Disintegrating Oral Tablet	PSN	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282313	rimegepant 75 MG Disintegrating Oral Tablet	PSN	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282320	rimegepant 75 MG Disintegrating Oral Tablet [Nurtec]	SBD	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282313	rimegepant 75 MG Disintegrating Oral Tablet	SCD	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282320	Nurtec 75 MG Disintegrating Oral Tablet	SY	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282320	Nurtec ODT 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral Tablet	SY	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31
2282313	rimegepant 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral Tablet	SY	9ef08e09-1098-35cc-e053-2a95a90a3e1d	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
72618-3001-4	72618300104	1 BLISTER PACK in 1 CARTON (72618-3001-4) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2024-12-18	1	Current