FDA.reportPublic FDA data

TOSYMRA

Product NDC
67857-812
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67857-812-612023-01-30C16284748780-1f386c649-f925-0266-e053-dadaa90a7c1aThese 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
67857-812-61TOSYMRA6 in 1 CARTONSPRAY61
67857-812-62TOSYMRA0.1 in 1 VIAL, SINGLE-DOSESPRAY0.11
67857-812-62TOSYMRA1 in 1 BLISTER PACKSPRAY11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67857-812-61EA - Each67857-812e152954d-1e9a-4cea-9149-b92e0842437c12019-10-07
67857-812-62EA - Each67857-8125201ae4e-8426-4b53-9040-0d17c65c6b6d12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67857-812TOSYMRA (SUMATRIPTAN) SPRAY [PROMIUS PHARMA, LLC.]1Legacy NDC, 3 package rows20190708_7260d567-3824-230d-836d-8065302baaec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
401978SUMAtriptan 10 MG/ACTUAT Nasal SprayPSN7260d567-3824-230d-836d-8065302baaec1
2178073tosymra 10 MG in 0.1 mL Nasal SprayPSN7260d567-3824-230d-836d-8065302baaec1
2178073sumatriptan 10 MG/ACTUAT Nasal Spray [Tosymra]SBD7260d567-3824-230d-836d-8065302baaec1
401978sumatriptan 10 MG/ACTUAT Nasal SpraySCD7260d567-3824-230d-836d-8065302baaec1
401978sumatriptan 10 MG/Spray Nasal SpraySY7260d567-3824-230d-836d-8065302baaec1
2178073Tosymra 10 MG/ACTUAT Nasal SpraySY7260d567-3824-230d-836d-8065302baaec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67857-812-61678570812616 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-DOSE6 blister pack2019-07-080000-00-00NoNoCurrent
67857-812-62678570812620.1 in 1 VIAL, SINGLE-DOSEHistorical