NDC 0299-5962

Dysport

Botulinum Toxin Type A

Dysport is a Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Botulinum Toxin Type A.

Product ID0299-5962_20b6057c-47dc-489c-b8c9-acb8409dac60
NDC0299-5962
Product TypeHuman Prescription Drug
Proprietary NameDysport
Generic NameBotulinum Toxin Type A
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-11-02
Marketing CategoryBLA / BLA
Application NumberBLA125274
Labeler NameGalderma Laboratories, L.P.
Substance NameBOTULINUM TOXIN TYPE A
Active Ingredient Strength300 U/1
Pharm ClassesAcetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0299-5962-01

1 VIAL in 1 CARTON (0299-5962-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2009-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0299-5962-01 [00299596201]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125274
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-02

NDC 0299-5962-30 [00299596230]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125274
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-02

Drug Details

Active Ingredients

IngredientStrength
BOTULINUM TOXIN TYPE A300 U/1

OpenFDA Data

SPL SET ID:71313a04-1349-4c26-b840-a39e4a3ddaed
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1789958
  • 1789956
  • Pharmacological Class

    • Acetylcholine Release Inhibitor [EPC]
    • Acetylcholine Release Inhibitors [MoA]

    NDC Crossover Matching brand name "Dysport" or generic name "Botulinum Toxin Type A"

    NDCBrand NameGeneric Name
    0299-5962DysportBotulinum Toxin Type A
    15054-0500DysportBotulinum Toxin Type A
    15054-0530DysportBotulinum Toxin Type A
    72960-112DAXXIFYbotulinum toxin type A

    Trademark Results [Dysport]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DYSPORT
    DYSPORT
    79033036 3366142 Live/Registered
    IPSEN BIOPHARM LIMITED
    2006-09-11
    DYSPORT
    DYSPORT
    77928954 3941865 Live/Registered
    Ipsen Biopharm Limited
    2010-02-05
    DYSPORT
    DYSPORT
    77633793 3759924 Live/Registered
    Ipsen Biopharm Limited
    2008-12-16
    DYSPORT
    DYSPORT
    74013177 1624403 Live/Registered
    PORTON PRODUCTS LIMITED
    1989-12-22

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