NDC 0023-3919

BOTOX Cosmetic

Onabotulinumtoxina

BOTOX Cosmetic is a 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 ID0023-3919_03473e87-ca9a-41fc-8f37-ae44eaf50635
NDC0023-3919
Product TypeHuman Prescription Drug
Proprietary NameBOTOX Cosmetic
Generic NameOnabotulinumtoxina
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2008-07-15
Marketing CategoryBLA / BLA
Application NumberBLA103000
Labeler NameAllergan, 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 0023-3919-50

1 VIAL, GLASS in 1 CARTON (0023-3919-50) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Marketing Start Date2008-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-3919-51 [00023391951]

BOTOX Cosmetic INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103000
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-07-15

NDC 0023-3919-50 [00023391950]

BOTOX Cosmetic INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-15

Drug Details

Active Ingredients

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

OpenFDA Data

SPL SET ID:485d9b71-6881-42c5-a620-a4360c7192ab
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860192
  • 1726296
  • 1726313
  • 1726293
  • UPC Code
  • 0300239232013
  • 0300233919507
  • Pharmacological Class

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

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

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

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