NDC 67857-809

ZEMBRACE SymTouch

Sumatriptan

ZEMBRACE SymTouch is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Promius Pharma, Llc. The primary component is Sumatriptan Succinate.

Product ID67857-809_30c45ab6-7687-a85b-9f68-55198481dbad
NDC67857-809
Product TypeHuman Prescription Drug
Proprietary NameZEMBRACE SymTouch
Generic NameSumatriptan
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-02-22
Marketing CategoryNDA / NDA
Application NumberNDA208223
Labeler NamePromius Pharma, LLC
Substance NameSUMATRIPTAN SUCCINATE
Active Ingredient Strength3 mg/1
Pharm ClassesSerotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67857-809-38

4 SYRINGE in 1 CARTON (67857-809-38) > 1 INJECTION, SOLUTION in 1 SYRINGE (67857-809-37)
Marketing Start Date2016-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67857-809-38 [67857080938]

ZEMBRACE SymTouch INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-22

NDC 67857-809-37 [67857080937]

ZEMBRACE SymTouch INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-22

Drug Details

Active Ingredients

IngredientStrength
SUMATRIPTAN SUCCINATE3 mg/1

OpenFDA Data

SPL SET ID:d565763d-b740-411d-bbb4-13536017d634
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738576
  • 1738581
  • UPC Code
  • 0367857809386
  • Pharmacological Class

    • Serotonin 1d Receptor Agonists [MoA]
    • Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
    • Serotonin 1b Receptor Agonists [MoA]

    Medicade Reported Pricing

    67857080938 ZEMBRACE SYMTOUCH 3 MG/0.5 ML

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "ZEMBRACE SymTouch" or generic name "Sumatriptan"

    NDCBrand NameGeneric Name
    0245-0809ZEMBRACE SYMTOUCHSumatriptan Succinate
    67857-809ZEMBRACE SymTouchZEMBRACE SymTouch
    0173-0449IMITREXsumatriptan
    0173-0478IMITREXsumatriptan
    0173-0479IMITREXsumatriptan
    0173-0523IMITREXsumatriptan
    0173-0524IMITREXsumatriptan
    0173-0735IMITREXsumatriptan
    0173-0736IMITREXsumatriptan
    0173-0737IMITREXsumatriptan
    0173-0739IMITREXsumatriptan
    0143-9638SUMATRIPTANsumatriptan
    0527-1818SumatriptanSumatriptan
    0527-1859SumatriptanSumatriptan
    0781-6523SUMATRIPTANsumatriptan
    0245-0812TOSYMRAsumatriptan

    Trademark Results [ZEMBRACE SymTouch]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZEMBRACE SYMTOUCH
    ZEMBRACE SYMTOUCH
    87150791 5478282 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    2016-08-25

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