Rizatriptan Benzoate

Product NDC: 0378-1404
11-digit product format: 003781404
Labeler code: 0378
Product ID: 0378-1404_884b2f91-8db1-4ea6-9332-acbae2ef2191
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rizatriptan benzoate
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA201993
Marketing category: ANDA
Marketing start: 2012-12-31
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-1404		D	Discontinued by firm		2026-10-16
excluded package	package	0378-1404	0378-1404-96	D	Discontinued by firm		2026-10-16

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
A201993-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2012-12-31
A201993-002	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	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201993-001	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	A201993-002	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	A201993-001	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	A201993-002	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	A201993-001	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	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201993-002	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	A201993-001	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	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201993-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201993-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201993-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201993-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201993-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201993-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201993-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201993-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201993-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201993-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201993-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201993-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201993-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201993-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201993-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201993-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201993-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201993-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201993-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201993-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201993-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201993-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201993-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201993-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201993-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201993-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201993-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201993-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201993-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201993-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201993-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201993-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201993-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201993-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201993-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201993-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201993-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201993-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201993-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201993-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201993-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201993-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1404-96	EA - Each	0378-1404	8504ab4a-265f-4385-951b-955a696b19b3	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 [MYLAN PHARMACEUTICALS INC.]	4
RIZATRIPTAN	ACTIVE MOIETY	51086HBW8G	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1404	RIZATRIPTAN BENZOATE TABLET [MYLAN PHARMACEUTICALS INC.]	8	Legacy NDC	20250101_30a602e9-495e-43ae-a4ea-acb564540b25.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1404-96	00378140496	12 TABLET in 1 BOTTLE, PLASTIC (0378-1404-96)	12 tablet	2012-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rizatriptan Benzoate	REMEDYREPACK INC.	2023-08-08	HUMAN PRESCRIPTION DRUG LABEL	11
Rizatriptan Benzoate	Mylan Pharmaceuticals Inc.	2019-11-27	HUMAN PRESCRIPTION DRUG LABEL	8