rizatriptan benzoate

Product NDC: 68462-466
Requested package NDC: 68462-466-99
11-digit product format: 684620466
Labeler code: 68462
Product ID: 68462-466_b98dc11a-813a-4a39-8d1b-93e8ae1bd95d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rizatriptan benzoate
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA201967
Marketing category: ANDA
Marketing start: 2012-12-31
Substance: RIZATRIPTAN BENZOATE
Active strength: 10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-466	68462-466-99	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A201967-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2012-12-31
A201967-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL			2012-12-31

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 · 88 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
2026-10-15 13:18:30	2026-09	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201967-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201967-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201967-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201967-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201967-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201967-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201967-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201967-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201967-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201967-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201967-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201967-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201967-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201967-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201967-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201967-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201967-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201967-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201967-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201967-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201967-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201967-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201967-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201967-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201967-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201967-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201967-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201967-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201967-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201967-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201967-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201967-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201967-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201967-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201967-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201967-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201967-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201967-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201967-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201967-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201967-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201967-002	AB	1	`ea1830bbd6c7…`

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	10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2791553-0b76-42f4-8d49-af3eda072bfb	Product name	1	20251117
707ffe6e-db52-42b0-9a65-a0c00213f04f	Product name	1	20231006
8b537454-32b8-7e64-1395-258682782d07	Product name	5	20170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68462-466-72	rizatriptan benzoate	12 in 1 CARTON	TABLET	12	11
68462-466-72	rizatriptan benzoate	1 in 1 POUCH	TABLET	1	11
68462-466-99	rizatriptan benzoate	1 in 1 POUCH	TABLET	1	11
68462-466-99	rizatriptan benzoate	18 in 1 CARTON	TABLET	18	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-466-99	EA - Each	68462-466	88405214-639d-4313-afda-eab30583ec03	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIZATRIPTAN BENZOATE	ACTIVE INGREDIENT	WR978S7QHH	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
RIZATRIPTAN	ACTIVE MOIETY	51086HBW8G	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	6
RIZATRIPTAN BENZOATE	ACTIVE INGREDIENT	WR978S7QHH	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
RIZATRIPTAN	ACTIVE MOIETY	51086HBW8G	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-466	RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	11	Current NDC, Legacy NDC, 4 package rows	20240104_99c66300-bd75-4b31-9fab-88c6e4b12688.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314209	rizatriptan benzoate 10 MG Oral Tablet	PSN	99c66300-bd75-4b31-9fab-88c6e4b12688	11
312840	rizatriptan benzoate 5 MG Oral Tablet	PSN	99c66300-bd75-4b31-9fab-88c6e4b12688	11
314209	rizatriptan 10 MG Oral Tablet	SCD	99c66300-bd75-4b31-9fab-88c6e4b12688	11
312840	rizatriptan 5 MG Oral Tablet	SCD	99c66300-bd75-4b31-9fab-88c6e4b12688	11
314209	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Tablet	SY	99c66300-bd75-4b31-9fab-88c6e4b12688	11
312840	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral Tablet	SY	99c66300-bd75-4b31-9fab-88c6e4b12688	11
314209	rizatriptan benzoate 10 MG Oral Tablet	PSN	09b35efc-b716-47c7-8f8e-00f7a5248460	1
314209	rizatriptan 10 MG Oral Tablet	SCD	09b35efc-b716-47c7-8f8e-00f7a5248460	1
314209	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Tablet	SY	09b35efc-b716-47c7-8f8e-00f7a5248460	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-466-99	68462046699	18 POUCH in 1 CARTON (68462-466-99) > 1 BLISTER PACK in 1 POUCH > 1 TABLET in 1 BLISTER PACK	18 pouch	2012-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
rizatriptan benzoate	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL	12
rizatriptan benzoate	A-S Medication Solutions	2017-12-22	HUMAN PRESCRIPTION DRUG LABEL	3
rizatriptan benzoate	Physicians Total Care, Inc.	2013-02-06	HUMAN PRESCRIPTION DRUG LABEL	1