Rizatriptan Benzoate ODT

Product NDC: 72189-609
11-digit product format: 721890609
Labeler code: 72189
Product ID: 72189-609_4d3aab18-54e6-cb65-e063-6394a90a9b26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate ODT
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Direct_rx
Application: ANDA203146
Marketing category: ANDA
Marketing start: 2025-01-20
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

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
A203146-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2014-09-19
A203146-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2014-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203146-001	AB
A203146-002	AB

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	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203146-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203146-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203146-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203146-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203146-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203146-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203146-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203146-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203146-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312837	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
2c29e066-c018-22e7-e063-6294a90a035c	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	Strength	SPL version
72189-609-18	Rizatriptan Benzoate ODT	18 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	18		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-609-18	EA - Each	72189-609	96f1a08c-14a7-45e1-a41a-8757e45f4fb4	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-609	RIZATRIPTAN BENZOATE ODT TABLET, ORALLY DISINTEGRATING [DIRECT_RX]	1	Current NDC, 1 package rows	20250122_2c29e066-c018-22e7-e063-6294a90a035c.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 ODT	RIZATRIPTAN BENZOATE ODT	Direct_rx	2c29e066-c018-22e7-e063-6294a90a035c	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203146 application number: ANDA203146 ndc (product): 72189-609
rizatriptan benzoate	RIZATRIPTAN BENZOATE	Macleods Pharmaceuticals Limited	57ed2505-28f1-4292-b3c3-a49bf0f7c683	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203146 application number: ANDA203146

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	2c29e066-c018-22e7-e063-6294a90a035c	2
312837	rizatriptan 10 MG Disintegrating Oral Tablet	SCD	2c29e066-c018-22e7-e063-6294a90a035c	2
312837	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet	SY	2c29e066-c018-22e7-e063-6294a90a035c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-609-18	72189060918	18 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-609-18)	2025-01-20	No	No	Current