Onzetra Xsail

Product NDC: 42847-311
Requested package NDC: 42847-311-08
11-digit product format: 428470311
Labeler code: 42847
Product ID: 42847-311_1b32d254-9be1-4601-9a8c-a039d4cd5a01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan succinate
Dosage form: CAPSULE
Route: NASAL
Labeler: Currax Pharmaceuticals LLC
Application: NDA206099
Marketing category: NDA
Marketing start: 2015-10-01
Substance: SUMATRIPTAN SUCCINATE
Active strength: 11 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42847-311	42847-311-08	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206099-001	ONZETRA XSAIL	SUMATRIPTAN SUCCINATE	EQ 11MG BASE	POWDER / NASAL		RLD, RS	2016-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206099-001	11571531	2026-02-23	U-1809		2023-05-19
N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10
N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10
N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10
N206099-001	10398859	2027-12-19		Drug product	2019-09-30
N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23
N206099-001	10722667	2028-12-30		Drug product	2020-08-25
N206099-001	10076615	2029-07-30	U-2010		2018-10-12
N206099-001	10076615	2029-07-30	U-2011		2018-10-12
N206099-001	10076615	2029-07-30	U-2404		2018-10-12
N206099-001	8550073	2029-10-22		Drug product	2016-02-23
N206099-001	8899229	2030-08-18		Drug product	2016-02-23
N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26
N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26
N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26
N206099-001	8978647	2030-12-06		Drug product	2016-02-23
N206099-001	10478574	2033-11-04	U-2404		2019-12-09
N206099-001	10076614	2034-10-20		Drug product	2018-10-12

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / INHALATION	RLD, RS	2016-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / INHALATION	RLD, RS	2016-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206099-001	ONZETRA XSAIL	EQ 11MG BASE	POWDER / NASAL	RLD, RS	2016-01-27	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 940 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10398859	2027-12-19		Drug product	2019-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10722667	2028-12-30		Drug product	2020-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10076615	2029-07-30	U-2011		2018-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10076615	2029-07-30	U-2010		2018-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10076615	2029-07-30	U-2404		2018-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	8550073	2029-10-22		Drug product	2016-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	8899229	2030-08-18		Drug product	2016-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	8978647	2030-12-06		Drug product	2016-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10478574	2033-11-04	U-2404		2019-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206099-001	10076614	2034-10-20		Drug product	2018-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10124132	2027-03-06	U-2010	Drug product	2018-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10124132	2027-03-06	U-1719	Drug product	2018-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10124132	2027-03-06	U-2011	Drug product	2018-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10398859	2027-12-19		Drug product	2019-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	8875704	2028-04-07	U-1809	Drug product	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10722667	2028-12-30		Drug product	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10076615	2029-07-30	U-2011		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10076615	2029-07-30	U-2010		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10076615	2029-07-30	U-2404		2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	8550073	2029-10-22		Drug product	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	8899229	2030-08-18		Drug product	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	9649456	2030-10-21	U-1719	Drug product	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	9649456	2030-10-21	U-2011	Drug product	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	9649456	2030-10-21	U-2010	Drug product	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	8978647	2030-12-06		Drug product	2016-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10478574	2033-11-04	U-2404		2019-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206099-001	10076614	2034-10-20		Drug product	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206099-001	7975690	2025-08-18	U-1809	Drug product	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206099-001	8590530	2025-09-15	U-1809	Drug product	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206099-001	9108015	2025-09-15		Drug product	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206099-001	11571531	2026-02-23	U-1809		2023-05-19	`31067a03dcf5…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2	Product name	4	20250724
2839c963-7eb3-970a-287f-ff1b6d381268	Product name	2	20250103
1e973b2d-e028-69cd-9258-4613ba80fdc5	Product name	3	20210512
3eb481d3-8b69-436f-82dd-4a66345568ab	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877c	Product name	1	20160303
49615343-b619-4365-8118-8f2ed6046e78	Product name	1	20160224
a6319377-430a-43db-82f9-30d1d9d89cf8	Product name	1	20151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42847-311-08	Onzetra Xsail	8 in 1 CARTON	CAPSULE	8		4
42847-311-08	Onzetra Xsail	2 in 1 POUCH	CAPSULE	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42847-311-08	EA - Each	42847-311	cefe8261-7872-481f-bbe7-7179d204901a	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42847-311	ONZETRA XSAIL (SUMATRIPTAN SUCCINATE) CAPSULE [CURRAX PHARMACEUTICALS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240423_a8a9889e-69b9-4a57-b8c0-d40b1025c559.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1739337	ONZETRA Xsail 11 MG Nasal Powder	PSN	a8a9889e-69b9-4a57-b8c0-d40b1025c559	4
1739332	SUMAtriptan 11 MG Nasal Powder	PSN	a8a9889e-69b9-4a57-b8c0-d40b1025c559	4
1739337	sumatriptan 11 MG Nasal Powder [Onzetra]	SBD	a8a9889e-69b9-4a57-b8c0-d40b1025c559	4
1739332	sumatriptan 11 MG Nasal Powder	SCD	a8a9889e-69b9-4a57-b8c0-d40b1025c559	4
1739337	Onzetra 11 MG Nasal Powder	SY	a8a9889e-69b9-4a57-b8c0-d40b1025c559	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42847-311-08	42847031108	8 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH	8 pouch	2015-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Onzetra Xsail - Currax Pharmaceuticals LLC	Currax Pharmaceuticals LLC	2024-04-18	HUMAN PRESCRIPTION DRUG LABEL	4