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 ID: 46783-165_0e962a66-7cd9-4fde-b1d5-3ca29baec002
• NDC: 46783-165
• Product Type: Human Prescription Drug
• Proprietary Name: Xeomin
• Generic Name: Incobotulinumtoxina
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2011-08-01
• Marketing Category: BLA / BLA
• Application Number: BLA125360
• Labeler Name: Merz North America, Inc.
• Substance Name: BOTULINUM TOXIN TYPE A
• Active Ingredient Strength: 50 [USP'U]/1
• Pharm Classes: Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

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 Date: 2011-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46783-165-01 [46783016501]

Xeomin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125360
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-08-01

Drug Details

Active Ingredients

Ingredient	Strength
BOTULINUM TOXIN TYPE A	50 [USP'U]/1

OpenFDA Data

• SPL SET ID: 3f35d6e0-3450-4abc-a0da-cc7b277e7c6e
• Manufacturer:
  • Merz North America, Inc.
• UNII:
  • E211KPY694
• 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"

NDC	Brand Name	Generic Name
0259-1605	Xeomin	incobotulinumtoxinA
0259-1610	Xeomin	incobotulinumtoxinA
0259-1620	Xeomin	incobotulinumtoxinA
0259-4110	Xeomin	incobotulinumtoxinA
0259-4150	Xeomin	incobotulinumtoxinA
46783-160	Xeomin	incobotulinumtoxinA
46783-161	Xeomin	incobotulinumtoxinA
46783-165	Xeomin	Xeomin