FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii8R78F6L9VO
Rxcui401978, 2178073

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
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70792-812-59Tosymra1 in 1 CARTONSPRAY13
70792-812-59Tosymra1 in 1 BLISTER PACKSPRAY13
70792-812-61Tosymra6 in 1 CARTONSPRAY63
70792-812-61Tosymra1 in 1 BLISTER PACKSPRAY13
70792-812-89Tosymra1 in 1 BLISTER PACKSPRAY13
70792-812-89Tosymra1 in 1 CARTONSPRAY13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70792-812-61EA - Each70792-8126fe85c7b-1439-488e-aa0a-a07631faf9a812025-05-14
70792-812-89EA - Each70792-812dc737879-a677-4c7b-addc-d7210be01c1e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70792-812TOSYMRA (SUMATRIPTAN) SPRAY [TONIX MEDICINES, INC.]3Current NDC, 6 package rows20250309_d9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401978SUMAtriptan 10 MG/ACTUAT Nasal SprayPSNd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53
2178073tosymra 10 MG in 0.1 mL Nasal SprayPSNd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53
2178073sumatriptan 10 MG/ACTUAT Nasal Spray [Tosymra]SBDd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53
401978sumatriptan 10 MG/ACTUAT Nasal SpraySCDd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53
401978sumatriptan 10 MG/Spray Nasal SpraySYd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53
2178073Tosymra 10 MG/ACTUAT Nasal SpraySYd9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70792-812-59707920812591 BLISTER PACK in 1 CARTON (70792-812-59) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY1 blister pack2024-07-01YesNoHistorical
70792-812-61707920812616 BLISTER PACK in 1 CARTON (70792-812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY6 blister pack2024-07-01NoNoHistorical
70792-812-89707920812891 BLISTER PACK in 1 CARTON (70792-812-89) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY1 blister pack2025-04-01NoNoHistorical