FDA.reportPublic FDA data

TOSYMRA

Product NDC
0245-0812
11-digit product format
002450812
Labeler code
0245
Product ID
0245-0812_27349402-73d3-3a2e-e063-6394a90a7099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA210884
Marketing category
NDA
Marketing start
2019-07-08
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210884-001TOSYMRASUMATRIPTAN10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210884-00182687912026-05-09Drug product2019-02-21
N210884-00184406312026-05-09U-1719Drug product2019-02-21
N210884-00192832802026-05-09Drug product2019-02-21
N210884-001106033052030-06-16U-1719Drug product2020-03-31
N210884-001113379622030-06-16U-1719Drug product2022-05-25
N210884-001120901392030-06-16Drug product2024-10-17
N210884-00196102802030-06-16U-1719Drug product2019-02-21
N210884-00199747702030-06-16U-1719Drug product2019-02-21
N210884-00192112822031-07-19U-1719Drug product2019-02-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210884-001TOSYMRA10MG/SPRAYSPRAY / NASALRLD, RS2019-01-25e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 9 · 330 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N210884-00182687912026-05-09Drug product2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-00184406312026-05-09U-1719Drug product2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-00192832802026-05-09Drug product2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-001106033052030-06-16U-1719Drug product2020-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-001113379622030-06-16U-1719Drug product2022-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-001120901392030-06-16Drug product2024-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-00196102802030-06-16U-1719Drug product2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-00199747702030-06-16U-1719Drug product2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210884-00192112822031-07-19U-1719Drug product2019-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210884-00182687912026-05-09Drug product2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-00184406312026-05-09U-1719Drug product2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-00192832802026-05-09Drug product2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-001106033052030-06-16U-1719Drug product2020-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-001113379622030-06-16U-1719Drug product2022-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-001120901392030-06-16Drug product2024-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-00196102802030-06-16U-1719Drug product2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-00199747702030-06-16U-1719Drug product2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210884-00192112822031-07-19U-1719Drug product2019-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00182687912026-05-09Drug product2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00184406312026-05-09U-1719Drug product2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00192832802026-05-09Drug product2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-001106033052030-06-16U-1719Drug product2020-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-001113379622030-06-16U-1719Drug product2022-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-001120901392030-06-16Drug product2024-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00196102802030-06-16U-1719Drug product2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00199747702030-06-16U-1719Drug product2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210884-00192112822031-07-19U-1719Drug product2019-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N210884-00182687912026-05-09Drug product2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-00184406312026-05-09U-1719Drug product2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-00192832802026-05-09Drug product2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-001106033052030-06-16U-1719Drug product2020-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-001113379622030-06-16U-1719Drug product2022-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-001120901392030-06-16Drug product2024-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-00196102802030-06-16U-1719Drug product2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-00199747702030-06-16U-1719Drug product2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210884-00192112822031-07-19U-1719Drug product2019-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210884-00182687912026-05-09Drug product2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210884-00184406312026-05-09U-1719Drug product2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210884-00192832802026-05-09Drug product2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210884-001106033052030-06-16U-1719Drug product2020-03-31fd3edfee7708…

Additional Listing Data#

Finished product
Yes
Brand name base
TOSYMRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN10 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8R78F6L9VOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
401978Internal RxNorm lookup
2178073Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
015a5cf9-f246-48bc-b91e-cd730a53d8aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0245-0812-612023-12-18C16284748780-10191ceaa-70fb-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TOSYMRA ® safely and effectively. See full prescribing information for TOSYMRA ® . TOSYMRA ® (sumatriptan) nasal spray Initial U.S. Approval: 1992
0245-0812-612023-07-28C16284748780-10191ceaa-70fb-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use TOSYMRA ® safely and effectively. See full prescribing information for TOSYMRA ® . TOSYMRA ® (sumatriptan) nasal spray Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0812-59TOSYMRA0.1 mL in 1 BOTTLE, SPRAYSPRAY0.16
0245-0812-61TOSYMRA6 in 1 CARTONSPRAY66
0245-0812-89TOSYMRA1 in 1 BLISTER PACKSPRAY16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0812-61EA - Each0245-08128b0903a2-987a-4c19-88f2-4491c11262f012021-10-08
0245-0812-89EA - Each0245-0812292ceb97-960c-467f-9478-3a2a4cad031812021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0812TOSYMRA (SUMATRIPTAN) SPRAY [UPSHER-SMITH LABORATORIES, LLC]6Current NDC, Legacy NDC, 3 package rows20241120_015a5cf9-f246-48bc-b91e-cd730a53d8aa.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TosymraSUMATRIPTANTonix Medicines, Inc.d9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a52025-02-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 210884
application number: NDA210884
TOSYMRASUMATRIPTANUpsher-Smith Laboratories, LLC015a5cf9-f246-48bc-b91e-cd730a53d8aa2024-11-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 210884
application number: NDA210884
ndc (product): 0245-0812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401978SUMAtriptan 10 MG/ACTUAT Nasal SprayPSN015a5cf9-f246-48bc-b91e-cd730a53d8aa6
2178073tosymra 10 MG in 0.1 mL Nasal SprayPSN015a5cf9-f246-48bc-b91e-cd730a53d8aa6
2178073sumatriptan 10 MG/ACTUAT Nasal Spray [Tosymra]SBD015a5cf9-f246-48bc-b91e-cd730a53d8aa6
401978sumatriptan 10 MG/ACTUAT Nasal SpraySCD015a5cf9-f246-48bc-b91e-cd730a53d8aa6
401978sumatriptan 10 MG/Spray Nasal SpraySY015a5cf9-f246-48bc-b91e-cd730a53d8aa6
2178073Tosymra 10 MG/ACTUAT Nasal SpraySY015a5cf9-f246-48bc-b91e-cd730a53d8aa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0812-59002450812590.1 mL in 1 BOTTLE, SPRAY0.1 mlHistorical
0245-0812-61002450812616 BLISTER PACK in 1 CARTON (0245-0812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK (0245-0812-89) / .1 mL in 1 BOTTLE, SPRAY (0245-0812-59) 6 blister pack2021-09-010000-00-00NoNoCurrent
0245-0812-89002450812891 in 1 BLISTER PACKHistorical