Home NDC 70792-812 Tosymra
Product NDC 70792-812
11-digit product format 707920812
Labeler code 70792
Product ID 70792-812_803144a8-2d17-47ac-98d0-515198ba722d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Tonix Medicines, Inc.
Application NDA210884
Marketing category NDA
Marketing start 2023-07-01
Substance SUMATRIPTAN
Active strength 10 mg/.1mL
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 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 N210884-001 TOSYMRA SUMATRIPTAN 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210884-001 8268791 2026-05-09 Drug product 2019-02-21 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 N210884-001 11337962 2030-06-16 U-1719 Drug product 2022-05-25 N210884-001 12090139 2030-06-16 Drug product 2024-10-17 N210884-001 9610280 2030-06-16 U-1719 Drug product 2019-02-21 N210884-001 9974770 2030-06-16 U-1719 Drug product 2019-02-21 N210884-001 9211282 2031-07-19 U-1719 Drug product 2019-02-21
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210884-001 TOSYMRA 10MG/SPRAY SPRAY / NASAL RLD, RS 2019-01-25 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 9 · 330 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 N210884-001 8268791 2026-05-09 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 11337962 2030-06-16 U-1719 Drug product 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 12090139 2030-06-16 Drug product 2024-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 9610280 2030-06-16 U-1719 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 9974770 2030-06-16 U-1719 Drug product 2019-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210884-001 9211282 2031-07-19 U-1719 Drug product 2019-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210884-001 8268791 2026-05-09 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 11337962 2030-06-16 U-1719 Drug product 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 12090139 2030-06-16 Drug product 2024-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 9610280 2030-06-16 U-1719 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 9974770 2030-06-16 U-1719 Drug product 2019-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210884-001 9211282 2031-07-19 U-1719 Drug product 2019-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 8268791 2026-05-09 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 11337962 2030-06-16 U-1719 Drug product 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 12090139 2030-06-16 Drug product 2024-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 9610280 2030-06-16 U-1719 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 9974770 2030-06-16 U-1719 Drug product 2019-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210884-001 9211282 2031-07-19 U-1719 Drug product 2019-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210884-001 8268791 2026-05-09 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 11337962 2030-06-16 U-1719 Drug product 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 12090139 2030-06-16 Drug product 2024-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 9610280 2030-06-16 U-1719 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 9974770 2030-06-16 U-1719 Drug product 2019-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210884-001 9211282 2031-07-19 U-1719 Drug product 2019-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210884-001 8268791 2026-05-09 Drug product 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210884-001 8440631 2026-05-09 U-1719 Drug product 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210884-001 9283280 2026-05-09 Drug product 2019-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210884-001 10603305 2030-06-16 U-1719 Drug product 2020-03-31 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Tosymra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN 10 mg/.1mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8R78F6L9VO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 401978 Internal RxNorm lookup 2178073 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70792-812 TOSYMRA (SUMATRIPTAN) SPRAY [TONIX MEDICINES, INC.] 3 Current NDC, 6 package rows 20250309_d9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70792-812-59 70792081259 1 BLISTER PACK in 1 CARTON (70792-812-59) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY 1 blister pack 2024-07-01 Yes No Current 70792-812-61 70792081261 6 BLISTER PACK in 1 CARTON (70792-812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY 6 blister pack 2024-07-01 No No Current 70792-812-89 70792081289 1 BLISTER PACK in 1 CARTON (70792-812-89) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY 1 blister pack 2025-04-01 No No Current