Rizatriptan Benzoate

Product NDC: 29300-269
11-digit product format: 293000269
Labeler code: 29300
Product ID: 29300-269_69ca309f-1132-40c9-b250-665c360968e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA207835
Marketing category: ANDA
Marketing start: 2017-03-07
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: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207835-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2017-03-07
A207835-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2017-03-07

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2017-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207835-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207835-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-03-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A207835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207835-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207835-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207835-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207835-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207835-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207835-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207835-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207835-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207835-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207835-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207835-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207835-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207835-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207835-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207835-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207835-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207835-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207835-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207835-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207835-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207835-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207835-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207835-002	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207835-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207835-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207835-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207835-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207835-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207835-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207835-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207835-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207835-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207835-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207835-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207835-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207835-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207835-002	AB	1	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rizatriptan Benzoate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIZATRIPTAN BENZOATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WR978S7QHH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312837	Internal RxNorm lookup
312839	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
3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
8b537454-32b8-7e64-1395-258682782d07	Product name	5	20170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-269-21	Rizatriptan Benzoate	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	6
29300-269-31	Rizatriptan Benzoate	3 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	3	6
29300-269-81	Rizatriptan Benzoate	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6	6
29300-269-91	Rizatriptan Benzoate	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-269-31	EA - Each	29300-269	f83d08db-3a9d-433c-bbdf-93919a02991d	1	2019-10-07
29300-269-81	EA - Each	29300-269	049a505d-de32-4e6e-86c9-9a9799abd74e	1	2019-10-07
29300-269-91	EA - Each	29300-269	721375a1-6ce8-4376-9185-092ab1419dad	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-269	RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [UNICHEM PHARMACEUTICALS (USA), INC.]	6	Current NDC, Legacy NDC, 4 package rows	20200512_3cdeccf6-36dd-4a9e-9687-2f7cce47af5f.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	Unichem Pharmaceuticals (USA), Inc.	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	2020-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207835 application number: ANDA207835 ndc (product): 29300-269
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	f5520526-1cc5-489f-b142-92f92fec77d3	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207835 application number: ANDA207835

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
312837	rizatriptan benzoate 10 MG Disintegrating Oral Tablet	PSN	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312839	rizatriptan benzoate 5 MG Disintegrating Oral Tablet	PSN	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312837	rizatriptan 10 MG Disintegrating Oral Tablet	SCD	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312839	rizatriptan 5 MG Disintegrating Oral Tablet	SCD	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312837	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet	SY	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312839	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral Tablet	SY	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	6
312837	rizatriptan benzoate 10 MG Disintegrating Oral Tablet	PSN	f5520526-1cc5-489f-b142-92f92fec77d3	1
312837	rizatriptan 10 MG Disintegrating Oral Tablet	SCD	f5520526-1cc5-489f-b142-92f92fec77d3	1
312837	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet	SY	f5520526-1cc5-489f-b142-92f92fec77d3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-269-21	29300026921	4 BLISTER PACK in 1 CARTON (29300-269-21) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)	4 blister pack	2017-07-05	0000-00-00	No	No	Current
29300-269-31	29300026931	3 in 1 BLISTER PACK						Historical
29300-269-81	29300026981	6 BLISTER PACK in 1 CARTON (29300-269-81) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)	6 blister pack	2017-07-05	0000-00-00	No	No	Current
29300-269-91	29300026991	3 BLISTER PACK in 1 CARTON (29300-269-91) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (29300-269-31)	3 blister pack	2017-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc. \| Unichem Laboratories Limited, India	2020-04-08	HUMAN PRESCRIPTION DRUG LABEL	6
Rizatriptan Benzoate	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	1