RIZAFILM

Product NDC: 35781-0605
11-digit product format: 357810605
Labeler code: 35781
Product ID: 35781-0605_33c5d784-a42c-4b10-e063-6394a90a9b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rizatriptan benzoate
Dosage form: FILM
Route: ORAL
Labeler: Gensco Laboratories LLC
Application: NDA205394
Marketing category: NDA
Marketing start: 2026-04-27
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

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
N205394-001	RIZAFILM	RIZATRIPTAN BENZOATE	EQ 10MG BASE	FILM / ORAL		RLD	2023-04-14
N205394-002	RIZAFILM	RIZATRIPTAN BENZOATE	EQ 5MG BASE	FILM / ORAL		RLD, RS	2026-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205394-001	9301948	2034-07-30		Drug substance, Drug product	2023-07-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD, RS	2023-04-14	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205394-001	RIZAFILM	EQ 10MG BASE	FILM / ORAL	RLD	2023-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205394-002	RIZAFILM	EQ 5MG BASE	FILM / ORAL	RLD, RS	2026-02-26	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205394-001	9301948	2034-07-30	Drug substance, Drug product	2023-07-26	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: RIZAFILM
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2634482	Internal RxNorm lookup
2634489	Internal RxNorm lookup
2672955	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
fa32794e-d26d-e0bf-e053-6294a90abb0e	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
8b537454-32b8-7e64-1395-258682782d07	Product name	5	20170424
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35781-0605-1	RIZAFILM	1 in 1 POUCH	FILM	1		5
35781-0605-8	RIZAFILM	18 in 1 CARTON	FILM	18		5

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIZAFILM	RIZATRIPTAN BENZOATE	Gensco Laboratories LLC	fa32794e-d26d-e0bf-e053-6294a90abb0e	2025-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205394 application number: NDA205394 ndc (product): 35781-0605

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
2672955	RizaFilm 10 MG Oral Film	PSN	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634482	rizatriptan 10 MG Oral Film	PSN	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634489	rizatriptan 5 MG Oral Film	PSN	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2672955	rizatriptan 10 MG Oral Film [Rizafilm]	SBD	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634482	rizatriptan 10 MG Oral Film	SCD	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634489	rizatriptan 5 MG Oral Film	SCD	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2672955	RizaFilm 10 MG (as rizatriptan benzoate 14.53 MG) Oral Film	SY	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2672955	Rizafilm 10 MG Oral Film	SY	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634482	rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral Film	SY	fa32794e-d26d-e0bf-e053-6294a90abb0e	5
2634489	rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG)Oral Film	SY	fa32794e-d26d-e0bf-e053-6294a90abb0e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
35781-0605-1	35781060501	1 in 1 POUCH					Historical
35781-0605-8	35781060508	18 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1)	18 pouch	2026-04-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RIZAFILM - Gensco Laboratories LLC \| IntelGenx Corp.	Gensco Laboratories LLC \| IntelGenx Corp.	2025-04-27	HUMAN PRESCRIPTION DRUG LABEL	5