ZEMBRACE SymTouch

Product NDC: 67857-809
11-digit product format: 678570809
Labeler code: 67857
Product ID: 67857-809_30c45ab6-7687-a85b-9f68-55198481dbad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Promius Pharma, LLC
Application: NDA208223
Marketing category: NDA
Marketing start: 2016-02-22
Marketing end: 0000-00-00
Substance: SUMATRIPTAN SUCCINATE
Active strength: 3 mg/1
Pharmacologic classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67857-809		I	Inactivated by FDA		2026-09-09
excluded package	package	67857-809	67857-809-38	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67857-809-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67857-809-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67857-809-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67857-809-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67857-809-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67857-809-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67857-809-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67857-809-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67857-809-38	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67857-809-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67857-809-38	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67857-809-38	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67857-809-38	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67857-809-38	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67857-809-38	`1332a3947898…`	`d4bfe170f9cd…`

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
N208223-001	ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD	2016-01-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208223-001	10537554	2036-01-29	U-72		2020-01-21
N208223-001	11364224	2036-01-29	U-72		2022-06-21
N208223-001	12097183	2036-01-29		Drug product	2024-10-24

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	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208223-001	ZEMBRACE SYMTOUCH	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD	2016-01-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 77 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	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208223-001	12097183	2036-01-29		Drug product	2024-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208223-001	11364224	2036-01-29	U-72		2022-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208223-001	10537554	2036-01-29	U-72		2020-01-21	`5c6f7cd8ea54…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67857-809-38	2023-01-30	C162847	48780-1	f386c649-a8cc-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZEMBRACE™ SymTouch™ safely and effectively. See full prescribing information for ZEMBRACE™ SymTouch™. ZEMBRACE™ SymTouch™ (sumatriptan succinate) Injection, for subcutaneous use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67857-809-37	ZEMBRACE SymTouch	1 in 1 SYRINGE	INJECTION, SOLUTION	1		5
67857-809-38	ZEMBRACE SymTouch	4 in 1 CARTON	INJECTION, SOLUTION	4		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67857-809-37	ML - Milliliter	67857-809	fe49d010-92f1-4d8c-99fb-0b34d0ad70f8	1	2016-04-04
67857-809-38	ML - Milliliter	67857-809	f2a2905a-68c7-4cdc-a171-a0713dac0746	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67857-809	ZEMBRACE SYMTOUCH (SUMATRIPTAN) INJECTION, SOLUTION [PROMIUS PHARMA, LLC]	5	Legacy NDC, 2 package rows	20190626_d565763d-b740-411d-bbb4-13536017d634.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
ZEMBRACE SYMTOUCH	SUMATRIPTAN SUCCINATE	Upsher-Smith laboratories, LLC	6e5b104f-2b9e-416e-92fb-ef1bdaea867d	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208223 application number: NDA208223
Zembrace SymTouch	SUMATRIPTAN SUCCINATE	Tonix Medicines, Inc.	3eb49807-fa9d-4a0d-9a3c-76de5b23b01b	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208223 application number: NDA208223

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE
8R78F6L9VO	SUMATRIPTAN	103628-46-2	sumatriptan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738576	SUMAtriptan 3 MG in 0.5 ML Auto-Injector	PSN	d565763d-b740-411d-bbb4-13536017d634	5
1738581	Zembrace 3 MG in 0.5 ML Auto-Injector	PSN	d565763d-b740-411d-bbb4-13536017d634	5
1738581	0.5 ML sumatriptan 6 MG/ML Auto-Injector [Zembrace]	SBD	d565763d-b740-411d-bbb4-13536017d634	5
1738576	0.5 ML sumatriptan 6 MG/ML Auto-Injector	SCD	d565763d-b740-411d-bbb4-13536017d634	5
1738576	sumatriptan (as succinate) 3 MG per 0.5 ML Auto-Injector	SY	d565763d-b740-411d-bbb4-13536017d634	5
1738576	sumatriptan 3 MG per 0.5 ML Auto-Injector	SY	d565763d-b740-411d-bbb4-13536017d634	5
1738581	Zembrace 3 MG per 0.5 ML Auto-Injector	SY	d565763d-b740-411d-bbb4-13536017d634	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67857-809-37	67857080937	1 in 1 SYRINGE						Historical
67857-809-38	67857080938	4 SYRINGE in 1 CARTON (67857-809-38) > 1 INJECTION, SOLUTION in 1 SYRINGE (67857-809-37)	4 syringe	2016-02-22	0000-00-00	No	No	Current