Home NDC 67857-812-61 TOSYMRA
Product NDC 67857-812
Requested package NDC 67857-812-61
11-digit product format 678570812
Labeler code 67857
Product ID 67857-812_cb524718-e675-acbc-5250-09a04d10c214
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Promius Pharma, LLC.
Application NDA210884
Marketing category NDA
Marketing start 2019-07-08
Marketing end 0000-00-00
Substance SUMATRIPTAN
Active strength 10 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 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 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…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67857-812-61 TOSYMRA 6 in 1 CARTON SPRAY 6 1 67857-812-62 TOSYMRA 0.1 in 1 VIAL, SINGLE-DOSE SPRAY 0.1 1 67857-812-62 TOSYMRA 1 in 1 BLISTER PACK SPRAY 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67857-812 TOSYMRA (SUMATRIPTAN) SPRAY [PROMIUS PHARMA, LLC.] 1 Legacy NDC, 3 package rows 20190708_7260d567-3824-230d-836d-8065302baaec.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 Marketing end Sample Exclude flag Status 67857-812-61 67857081261 6 BLISTER PACK in 1 CARTON (67857-812-61) > 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (67857-812-62) > .1 SPRAY in 1 VIAL, SINGLE-DOSE 6 blister pack 2019-07-08 0000-00-00 No No Current