Rizatriptan Benzoate

Product NDC: 71335-2982
11-digit product format: 713352982
Labeler code: 71335
Product ID: 71335-2982_f8d2892f-9943-4084-9b22-d1eabc695ac3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan Benzoate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203062
Marketing category: ANDA
Marketing start: 2013-07-01
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
A203062-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-07-01
A203062-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203062-001	AB
A203062-002	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	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`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	A203062-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203062-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203062-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203062-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203062-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203062-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203062-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203062-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203062-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203062-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203062-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203062-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203062-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203062-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203062-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203062-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203062-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203062-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rizatriptan Benzoate
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
11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	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
71335-2982-1	Rizatriptan Benzoate	9 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	9		1

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 71335-2982
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Advanced Rx of Tennessee, LLC	4137a02e-dcec-c14c-e063-6294a90aa44f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	07605de4-bef2-70e8-e063-6394a90a33cc	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	a8e37688-426c-4290-933d-54a34ae86000	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	REMEDYREPACK INC.	1e547fac-a9e5-4c7b-adba-4e6b75141183	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Asclemed USA, Inc.	8fa794f4-4253-485d-b4ee-986178031339	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate ODT	RIZATRIPTAN BENZOATE ODT	Direct Rx	db489d19-1509-c979-e053-2a95a90a4410	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	74971372-75c6-4682-adbf-1c8e7b748fc1	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	2337e102-8df0-4e7f-81d8-5cb86cd48674	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	NuCare Pharmaceuticals,Inc.	106dd370-c09c-556a-e063-6394a90acfed	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	80c124ab-a083-4184-ba6b-199a7681b5d1	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062

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	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	1
312837	rizatriptan 10 MG Disintegrating Oral Tablet	SCD	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	1
312837	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet	SY	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2982-1	71335298201	9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2982-1)	2026-02-04	No	No	Current