ZEMBRACE SYMTOUCH

Product NDC
0245-0809
11-digit product format
002450809
Labeler code
0245
Product ID
0245-0809_47f6d684-3580-1929-e063-6394a90ac772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Upsher-Smith laboratories, LLC
Application
NDA208223
Marketing category
NDA
Marketing start
2016-02-22
Marketing end
2026-08-31
Substance
SUMATRIPTAN SUCCINATE
Active strength
3 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZEMBRACE SYMTOUCH

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE3 mg/1

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
0245-0809-38ZEMBRACE SYMTOUCH4 in 1 CARTONINJECTION, SOLUTION48
0245-0809-89ZEMBRACE SYMTOUCH1 in 1 SYRINGEINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0809-38ML - Milliliter0245-0809947c0674-ea3f-4051-a98b-e6814d8b540912021-02-05
0245-0809-89ML - Milliliter0245-080909db8e5f-3912-4f0f-9239-1b71bbe9083b12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0809ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) INJECTION, SOLUTION [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20241120_6e5b104f-2b9e-416e-92fb-ef1bdaea867d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738576SUMAtriptan 3 MG in 0.5 ML Auto-InjectorPSN6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
1738581Zembrace 3 MG in 0.5 ML Auto-InjectorPSN6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
17385810.5 ML sumatriptan 6 MG/ML Auto-Injector [Zembrace]SBD6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
17385760.5 ML sumatriptan 6 MG/ML Auto-InjectorSCD6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
1738576sumatriptan (as succinate) 3 MG per 0.5 ML Auto-InjectorSY6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
1738576sumatriptan 3 MG per 0.5 ML Auto-InjectorSY6e5b104f-2b9e-416e-92fb-ef1bdaea867d8
1738581Zembrace 3 MG per 0.5 ML Auto-InjectorSY6e5b104f-2b9e-416e-92fb-ef1bdaea867d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0809-38002450809384 SYRINGE in 1 CARTON (0245-0809-38) / 1 INJECTION, SOLUTION in 1 SYRINGE (0245-0809-89) 4 syringe2021-01-042026-08-31NoNoCurrent
0245-0809-89002450809891 in 1 SYRINGEHistorical