Rizatriptan benzoate

Product NDC: 62135-998
11-digit product format: 621350998
Labeler code: 62135
Product ID: 62135-998_5b65c71e-7c93-7d74-e063-6294a90a0597
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA078739
Marketing category: ANDA
Marketing start: 2013-07-01
Substance: RIZATRIPTAN BENZOATE
Active strength: 5 mg/1
Pharmacologic classes: Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 43.

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
A078739-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2013-07-01
A078739-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2013-07-01

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078739-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078739-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078739-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078739-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078739-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078739-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078739-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078739-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078739-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078739-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078739-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078739-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078739-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078739-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078739-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078739-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078739-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078739-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078739-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078739-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078739-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078739-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078739-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078739-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078739-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078739-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078739-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078739-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A078739-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078739-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078739-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078739-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIZATRIPTAN BENZOATE	5 mg/1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WR978S7QHH	RIZATRIPTAN BENZOATE	145202-66-0	RIZATRIPTAN BENZOATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62135-998-17	62135099817	18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-998-17)	2026-08-26	No	No	Current