NDC 0259-1605

Xeomin

Incobotulinumtoxina

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

• Product ID: 0259-1605_1a549ffb-8756-4989-861d-e8eb1b738823
• NDC: 0259-1605
• 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: 2010-09-01
• Marketing Category: BLA / BLA
• Application Number: BLA125360
• Labeler Name: Merz Pharmaceuticals, LLC
• 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 0259-1605-01

1 VIAL, SINGLE-USE in 1 CARTON (0259-1605-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2010-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0259-1605-01 [00259160501]

Xeomin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125360
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-01

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: ccdc3aae-6e2d-4cd0-a51c-8375bfee9458
• Manufacturer:
  • Merz Pharmaceuticals, LLC
• UNII:
  • E211KPY694
• RxNorm Concept Unique ID - RxCUI:
  • 1000107
  • 1009459
  • 1009456
  • 1732161
  • 1732157
  • 1732165
• UPC Code:
  • 0302591620019
  • 0302591605016
  • 0302591610010

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