Rizatriptan Benzoate

Product NDC: 76282-462
Requested package NDC: 76282-462-18
11-digit product format: 762820462
Labeler code: 76282
Product ID: 76282-462_5c316585-d6da-4044-a99d-8aba3bdf6afa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate
Dosage form: TABLET
Route: ORAL
Labeler: Exelan Pharmaceuticals Inc.
Application: ANDA204339
Marketing category: ANDA
Marketing start: 2017-06-06
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76282-462	76282-462-18	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204339-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2013-07-01
A204339-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / 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 · 84 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
2026-08-18 06:07:40	2026-07	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

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	A204339-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204339-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204339-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204339-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204339-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204339-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204339-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204339-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204339-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204339-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204339-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204339-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204339-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204339-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204339-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204339-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204339-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204339-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204339-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204339-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204339-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204339-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204339-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204339-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204339-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204339-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204339-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204339-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204339-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204339-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204339-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204339-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204339-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204339-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204339-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204339-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204339-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204339-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204339-002	AB	1	`3f0d92c62455…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76282-462-06	2022-01-28	C162847	48780-1	d6a99b39-99c4-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE TABLETS safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE TABLETS. RIZATRIPTAN benzoate tablets, for oral use Initial U.S. Approval: 1998
76282-462-18	2022-01-28	C162847	48780-1	d6a99b39-99c4-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE TABLETS safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE TABLETS. RIZATRIPTAN benzoate tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76282-462-06	Rizatriptan Benzoate	6 in 1 BLISTER PACK	TABLET	6		5
76282-462-18	Rizatriptan Benzoate	3 in 1 CARTON	TABLET	3		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-462-06	EA - Each	76282-462	0706e8d7-0bb5-4381-8676-b647f109d608	1	2017-07-07
76282-462-18	EA - Each	76282-462	653470b0-3422-470a-89cb-6350ac665031	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-462	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET [EXELAN PHARMACEUTICALS INC.]	5	Legacy NDC, 2 package rows	20201126_9e82135a-3371-4012-92af-0cc7d7d4d0e3.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
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	673d584c-0691-d2fb-e053-2991aa0a7797	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204339 application number: ANDA204339
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Cipla USA Inc.	f462a507-921c-41c2-93ba-36003b6e8914	2022-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204339 application number: ANDA204339

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	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5
312840	rizatriptan benzoate 5 MG Oral Tablet	PSN	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5
314209	rizatriptan 10 MG Oral Tablet	SCD	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5
312840	rizatriptan 5 MG Oral Tablet	SCD	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5
314209	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Tablet	SY	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5
312840	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral Tablet	SY	9e82135a-3371-4012-92af-0cc7d7d4d0e3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-462-18	76282046218	3 TABLET in 1 CARTON (76282-462-18)	3 tablet	2017-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rizatriptan Benzoate	Exelan Pharmaceuticals Inc. \| InvaGen Pharmaceuticals, Inc \| Nutra-Med Packaging Inc.	2020-11-01	HUMAN PRESCRIPTION DRUG LABEL	5