RIZATRIPTAN BENZOATE

Product NDC: 43817-135
Requested package NDC: 43817-135-04
11-digit product format: 438170135
Labeler code: 43817
Product ID: 43817-135_28d0cbcc-59cc-7cf4-e063-6294a90a9b53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rizatriptan benzoate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Panacea Biotec Limited
Application: ANDA204722
Marketing category: ANDA
Marketing start: 2017-01-17
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
A204722-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2017-01-11
A204722-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2017-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204722-001	AB
A204722-002	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	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204722-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204722-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2017-01-11	`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	A204722-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204722-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204722-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204722-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204722-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204722-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204722-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204722-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204722-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204722-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204722-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204722-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204722-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204722-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204722-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204722-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204722-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204722-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204722-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204722-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204722-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204722-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204722-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204722-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204722-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204722-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204722-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204722-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204722-002	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	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
9c70370d-72ac-e062-e25c-97d57e6397ab	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
43817-135-03	RIZATRIPTAN BENZOATE	3 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	3		8
43817-135-04	RIZATRIPTAN BENZOATE	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43817-135	RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [PANACEA BIOTEC LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20241210_9c70370d-72ac-e062-e25c-97d57e6397ab.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	Panacea Biotec Limited	9c70370d-72ac-e062-e25c-97d57e6397ab	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204722 application number: ANDA204722 ndc (package): 43817-135-04 ndc (product): 43817-135 ndc11 (package): 43817013504
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Bionpharma Inc.,	91e160d6-f23f-e5e0-baec-908b2d25ce3c	2021-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204722 application number: ANDA204722

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	9c70370d-72ac-e062-e25c-97d57e6397ab	8
312839	rizatriptan benzoate 5 MG Disintegrating Oral Tablet	PSN	9c70370d-72ac-e062-e25c-97d57e6397ab	8
312837	rizatriptan 10 MG Disintegrating Oral Tablet	SCD	9c70370d-72ac-e062-e25c-97d57e6397ab	8
312839	rizatriptan 5 MG Disintegrating Oral Tablet	SCD	9c70370d-72ac-e062-e25c-97d57e6397ab	8
312837	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet	SY	9c70370d-72ac-e062-e25c-97d57e6397ab	8
312839	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral Tablet	SY	9c70370d-72ac-e062-e25c-97d57e6397ab	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43817-135-04	43817013504	6 BLISTER PACK in 1 CARTON (43817-135-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-135-03)	6 blister pack	2017-01-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RIZATRIPTAN BENZOATE	Panacea Biotec Limited \| Panacea Biotec Pharma Limited	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	8