Rizatriptan

Product NDC: 71335-2980
11-digit product format: 713352980
Labeler code: 71335
Product ID: 71335-2980_32eb56b6-9cb6-4ad2-bffb-1cf9af4bfd2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rizatriptan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203147
Marketing category: ANDA
Marketing start: 2014-03-11
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
A203147-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB		2014-02-11
A203147-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB		2014-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203147-001	AB
A203147-002	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	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203147-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2014-02-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203147-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2014-02-11	`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	A203147-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203147-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203147-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203147-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203147-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203147-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203147-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203147-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203147-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203147-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203147-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203147-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203147-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203147-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203147-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203147-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203147-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203147-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203147-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203147-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203147-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203147-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203147-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203147-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203147-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203147-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203147-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203147-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203147-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203147-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203147-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203147-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203147-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203147-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203147-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203147-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203147-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203147-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203147-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203147-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rizatriptan
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314209	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
f000d96c-42a0-4aac-96ca-8cef289979ce	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
71335-2980-1	Rizatriptan	12 in 1 BOTTLE	TABLET, FILM COATED	12		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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Direct_Rx	f754388d-77f1-0d8d-e053-6394a90a7b7e	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203147 application number: ANDA203147
Rizatriptan	RIZATRIPTAN	Bryant Ranch Prepack	f000d96c-42a0-4aac-96ca-8cef289979ce	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203147 application number: ANDA203147 ndc (product): 71335-2980
Rizatriptan	RIZATRIPTAN	A-S Medication Solutions	34395ed2-97b7-4220-9089-0e90169d3083	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203147 application number: ANDA203147
Rizatriptan	RIZATRIPTAN	Bryant Ranch Prepack	7db81532-6781-47f7-a5cd-6aeda9b8bf6f	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203147 application number: ANDA203147
Rizatriptan	RIZATRIPTAN	Macleods Pharmaceuticals Limited	27bc2cfc-fefb-4b50-a0dc-6268c69b4902	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203147 application number: ANDA203147

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WR978S7QHH	RIZATRIPTAN BENZOATE	145202-66-0	RIZATRIPTAN BENZOATE
51086HBW8G	RIZATRIPTAN	144034-80-0	Rizatriptan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314209	rizatriptan benzoate 10 MG Oral Tablet	PSN	f000d96c-42a0-4aac-96ca-8cef289979ce	1
314209	rizatriptan 10 MG Oral Tablet	SCD	f000d96c-42a0-4aac-96ca-8cef289979ce	1
314209	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Tablet	SY	f000d96c-42a0-4aac-96ca-8cef289979ce	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2980-1	71335298001	12 TABLET, FILM COATED in 1 BOTTLE (71335-2980-1)	2025-11-26	No	No	Current