NDC 46783-165

Xeomin

Incobotulinumtoxina

Xeomin is a Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merz North America, Inc.. The primary component is Botulinum Toxin Type A.

Product ID46783-165_0e962a66-7cd9-4fde-b1d5-3ca29baec002
NDC46783-165
Product TypeHuman Prescription Drug
Proprietary NameXeomin
Generic NameIncobotulinumtoxina
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2011-08-01
Marketing CategoryBLA / BLA
Application NumberBLA125360
Labeler NameMerz North America, Inc.
Substance NameBOTULINUM TOXIN TYPE A
Active Ingredient Strength50 [USP'U]/1
Pharm ClassesAcetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 46783-165-01

1 VIAL, SINGLE-USE in 1 CARTON (46783-165-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Marketing Start Date2011-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46783-165-01 [46783016501]

Xeomin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-08-01

Drug Details

Active Ingredients

IngredientStrength
BOTULINUM TOXIN TYPE A50 [USP'U]/1

OpenFDA Data

SPL SET ID:3f35d6e0-3450-4abc-a0da-cc7b277e7c6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1009456
  • 1732161
  • 1732157
  • 1009459
  • UPC Code
  • 0346783165018
  • 0346783160105
  • 0346783160013
  • 0346783161010
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Xeomin" or generic name "Incobotulinumtoxina"

    NDCBrand NameGeneric Name
    0259-1605XeominincobotulinumtoxinA
    0259-1610XeominincobotulinumtoxinA
    0259-1620XeominincobotulinumtoxinA
    0259-4110XeominincobotulinumtoxinA
    0259-4150XeominincobotulinumtoxinA
    46783-160XeominincobotulinumtoxinA
    46783-161XeominincobotulinumtoxinA
    46783-165XeominXeomin

    Trademark Results [Xeomin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XEOMIN
    XEOMIN
    79371939 not registered Live/Pending
    Merz Pharma GmbH & Co. KGaA
    2023-02-22
    XEOMIN
    XEOMIN
    77910865 3898981 Live/Registered
    MERZ PHARMA GmbH & Co. KGaA
    2010-01-13
    XEOMIN
    XEOMIN
    76533879 2918539 Dead/Cancelled
    Merz Pharma GmbH & Co. KGaA
    2003-08-01

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