FDA.reportPublic FDA data

Zembrace SymTouch

Product NDC
70792-809
11-digit product format
707920809
Labeler code
70792
Product ID
70792-809_82e7bcd6-ebe3-4e29-85c5-f01c901ee0a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Tonix Medicines, Inc.
Application
NDA208223
Marketing category
NDA
Marketing start
2023-07-01
Substance
SUMATRIPTAN SUCCINATE
Active strength
3 mg/.5mL
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
Zembrace SymTouch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE3 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui1738576, 1738581

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
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
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70792-809-38Zembrace SymTouch4 in 1 CARTONSOLUTION43
70792-809-38Zembrace SymTouch1 in 1 BLISTER PACKSOLUTION13
70792-809-39Zembrace SymTouch1 in 1 CARTONSOLUTION13
70792-809-39Zembrace SymTouch1 in 1 BLISTER PACKSOLUTION13
70792-809-89Zembrace SymTouch1 in 1 BLISTER PACKSOLUTION13
70792-809-89Zembrace SymTouch1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70792-809-38ML - Milliliter70792-809d892760b-27ab-4d85-a917-5cab4516418a12025-05-14
70792-809-89ML - Milliliter70792-80990040a78-7a9f-435c-bffd-68edd5469b9812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70792-809ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) SOLUTION [TONIX MEDICINES, INC.]3Current NDC, 6 package rows20250309_3eb49807-fa9d-4a0d-9a3c-76de5b23b01b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738576SUMAtriptan 3 MG in 0.5 ML Auto-InjectorPSN3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
1738581Zembrace 3 MG in 0.5 ML Auto-InjectorPSN3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
17385810.5 ML sumatriptan 6 MG/ML Auto-Injector [Zembrace]SBD3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
17385760.5 ML sumatriptan 6 MG/ML Auto-InjectorSCD3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
1738576sumatriptan (as succinate) 3 MG per 0.5 ML Auto-InjectorSY3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
1738576sumatriptan 3 MG per 0.5 ML Auto-InjectorSY3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3
1738581Zembrace 3 MG per 0.5 ML Auto-InjectorSY3eb49807-fa9d-4a0d-9a3c-76de5b23b01b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70792-809-38707920809384 BLISTER PACK in 1 CARTON (70792-809-38) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE4 blister pack2024-07-01NoNoCurrent
70792-809-39707920809391 BLISTER PACK in 1 CARTON (70792-809-39) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2024-07-01YesNoCurrent
70792-809-89707920809891 BLISTER PACK in 1 CARTON (70792-809-89) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2025-04-01YesNoCurrent