NDC 0023-3921

BOTOX

Onabotulinumtoxina

BOTOX is a Intradermal; Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Botulinum Toxin Type A.

Product ID0023-3921_03d9dd80-7656-4f9d-9760-59ac600ad1d3
NDC0023-3921
Product TypeHuman Prescription Drug
Proprietary NameBOTOX
Generic NameOnabotulinumtoxina
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRADERMAL; INTRAMUSCULAR
Marketing Start Date2010-01-11
Marketing CategoryBLA / BLA
Application NumberBLA103000
Labeler NameAllergan, Inc.
Substance NameBOTULINUM TOXIN TYPE A
Active Ingredient Strength200 [USP'U]/1
Pharm ClassesAcetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0023-3921-02

1 VIAL in 1 CARTON (0023-3921-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2010-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-3921-02 [00023392102]

BOTOX INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-11

NDC 0023-3921-03 [00023392103]

BOTOX INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103000
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-11

Drug Details

Active Ingredients

IngredientStrength
BOTULINUM TOXIN TYPE A200 [USP'U]/1

OpenFDA Data

SPL SET ID:33d066a9-34ff-4a1a-b38b-d10983df3300
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860192
  • 897366
  • 897368
  • 860195
  • Pharmacological Class

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

    NDC Crossover Matching brand name "BOTOX" or generic name "Onabotulinumtoxina"

    NDCBrand NameGeneric Name
    0023-1145BOTOXonabotulinumtoxinA
    0023-3921BOTOXonabotulinumtoxinA
    0023-3919BOTOX CosmeticonabotulinumtoxinA
    0023-9232BOTOX CosmeticonabotulinumtoxinA

    Trademark Results [BOTOX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BOTOX
    BOTOX
    87701996 not registered Dead/Abandoned
    Allergan, Inc.
    2017-11-29
    BOTOX
    BOTOX
    87701895 not registered Dead/Abandoned
    Allergan, Inc.
    2017-11-29
    BOTOX
    BOTOX
    87690022 not registered Dead/Abandoned
    Allergan, Inc.
    2017-11-17
    BOTOX
    BOTOX
    87519959 not registered Dead/Abandoned
    Gems Style Inc.
    2017-07-07
    BOTOX
    BOTOX
    79002971 not registered Dead/Abandoned
    ALLERGAN, INC.
    2004-03-12
    BOTOX
    BOTOX
    78041618 2510675 Live/Registered
    Allergan, Inc.
    2001-01-03
    BOTOX
    BOTOX
    78041612 2510673 Live/Registered
    Allergan, Inc.
    2001-01-03
    BOTOX
    BOTOX
    77099166 3454647 Dead/Cancelled
    Allergan, Inc.
    2007-02-05
    BOTOX
    BOTOX
    76394796 not registered Dead/Abandoned
    Y.Z.Y. INC.
    2002-04-10
    BOTOX
    BOTOX
    74308779 not registered Dead/Abandoned
    ALLERGAN, INC.
    1992-08-26
    BOTOX
    BOTOX
    74282086 1814396 Live/Registered
    ALLERGAN, INC.
    1992-06-04
    BOTOX
    BOTOX
    74136930 1709160 Live/Registered
    ALLERGAN, INC.
    1991-02-06

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.