Home NDC 70792-809 Zembrace SymTouch
Product NDC 70792-809
11-digit product format 707920809
Labeler code 70792
Product ID 70792-809_82e7bcd6-ebe3-4e29-85c5-f01c901ee0a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan Succinate
Dosage form SOLUTION
Route SUBCUTANEOUS
Labeler Tonix Medicines, Inc.
Application NDA208223
Marketing category NDA
Marketing start 2023-07-01
Substance SUMATRIPTAN SUCCINATE
Active strength 3 mg/.5mL
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 43 .
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 2 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208223-001 10537554 2036-01-29 U-72 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208223-001 11364224 2036-01-29 U-72 2022-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Zembrace SymTouch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 3 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J8BDZ68989 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738576 Internal RxNorm lookup 1738581 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70792-809-38 Zembrace SymTouch 4 in 1 CARTON SOLUTION 4 3 70792-809-38 Zembrace SymTouch 1 in 1 BLISTER PACK SOLUTION 1 3 70792-809-39 Zembrace SymTouch 1 in 1 CARTON SOLUTION 1 3 70792-809-39 Zembrace SymTouch 1 in 1 BLISTER PACK SOLUTION 1 3 70792-809-89 Zembrace SymTouch 1 in 1 BLISTER PACK SOLUTION 1 3 70792-809-89 Zembrace SymTouch 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70792-809 ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) SOLUTION [TONIX MEDICINES, INC.] 3 Current NDC, 6 package rows 20250309_3eb49807-fa9d-4a0d-9a3c-76de5b23b01b.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70792-809-38 70792080938 4 BLISTER PACK in 1 CARTON (70792-809-38) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 4 blister pack 2024-07-01 No No Current 70792-809-39 70792080939 1 BLISTER PACK in 1 CARTON (70792-809-39) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 1 blister pack 2024-07-01 Yes No Current 70792-809-89 70792080989 1 BLISTER PACK in 1 CARTON (70792-809-89) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 1 blister pack 2025-04-01 Yes No Current