Rizatriptan Benzoate

Product NDC: 72189-512
Requested package NDC: 72189-512-18
11-digit product format: 721890512
Labeler code: 72189
Product ID: 72189-512_2c4e6424-181c-1db8-e063-6294a90a52d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA202490
Marketing category: ANDA
Marketing start: 2023-09-11
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: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-512	72189-512-18	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-512	72189-512-18	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A202490-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB		2012-12-31
A202490-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB		2012-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202490-001	AB
A202490-002	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	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202490-002	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	A202490-001	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	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	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	A202490-001	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	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202490-002	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	A202490-001	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	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`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	A202490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202490-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202490-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202490-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202490-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202490-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202490-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202490-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202490-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202490-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202490-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202490-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202490-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202490-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202490-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202490-002	AB	1	`782e0a99824c…`

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	5 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
312840	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
05150193-cc2f-8b41-e063-6394a90a184c	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
8b537454-32b8-7e64-1395-258682782d07	Product name	5	20170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-512-18	Rizatriptan Benzoate	18 in 1 BOTTLE	TABLET	18		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-512-18	EA - Each	72189-512	fadac402-757d-47a4-a334-e5609d3019a3	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-512	RIZATRIPTAN BENZOATE TABLET [DIRECT_RX]	3	Current NDC, 1 package rows	20250123_05150193-cc2f-8b41-e063-6394a90a184c.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 · 12 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): 202490 application number: ANDA202490
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	direct rx	b3d981bc-3c9e-8a9e-e053-2995a90a8f65	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	A-S Medication Solutions	187204ef-5370-476a-84b1-e3c54b60c6c2	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	e7414f2d-d7cf-41e5-b457-f5850e8bb7a7	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Direct_Rx	05150193-cc2f-8b41-e063-6394a90a184c	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (package): 72189-512-18 ndc (product): 72189-512 ndc11 (package): 72189051218
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	2598cfb1-f875-43a5-aa10-246e026e9695	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	03b5a887-d689-48a6-bd41-ae1ab4ae4990	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	01762e5f-db9a-49b3-8da1-60967970a318	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	075f47ee-88d1-102b-e063-6394a90acbf8	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	222f77ff-d3f7-40f9-989c-e5902f44ef1e	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	4a5b43f6-a5ea-4d6f-941f-3c19f242c896	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490

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
312840	rizatriptan benzoate 5 MG Oral Tablet	PSN	05150193-cc2f-8b41-e063-6394a90a184c	3
312840	rizatriptan 5 MG Oral Tablet	SCD	05150193-cc2f-8b41-e063-6394a90a184c	3
312840	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral Tablet	SY	05150193-cc2f-8b41-e063-6394a90a184c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-512-18	72189051218	18 TABLET in 1 BOTTLE (72189-512-18)	18 tablet	2023-09-11	No	No	Current