NDC 15054-0500

Dysport

Botulinum Toxin Type A

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

• Product ID: 15054-0500_3f3dcad4-ba39-4ac0-bf4a-7c35044ab15f
• NDC: 15054-0500
• Product Type: Human Prescription Drug
• Proprietary Name: Dysport
• Generic Name: Botulinum Toxin Type A
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2009-11-02
• Marketing Category: BLA / BLA
• Application Number: BLA125274
• Labeler Name: Ipsen Biopharmaceuticals, Inc.
• Substance Name: BOTULINUM TOXIN TYPE A
• Active Ingredient Strength: 500 U/1
• Pharm Classes: Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 15054-0500-1

1 VIAL in 1 CARTON (15054-0500-1) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2009-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15054-0500-1 [15054050001]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125274
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-02

NDC 15054-0500-2 [15054050002]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125274
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-02

NDC 15054-0500-9 [15054050009]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125274
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-02

Drug Details

Active Ingredients

Ingredient	Strength
BOTULINUM TOXIN TYPE A	500 U/1

OpenFDA Data

• SPL SET ID: 97513722-8426-4ce3-b85d-0e08e436a140
• Manufacturer:
  • Ipsen Biopharmaceuticals, Inc.
• UNII:
  • E211KPY694
• RxNorm Concept Unique ID - RxCUI:
  • 1789953
  • 1789950
  • 1789956
  • 1789958

Pharmacological Class

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

NDC Crossover Matching brand name "Dysport" or generic name "Botulinum Toxin Type A"

NDC	Brand Name	Generic Name
0299-5962	Dysport	Botulinum Toxin Type A
15054-0500	Dysport	Botulinum Toxin Type A
15054-0530	Dysport	Botulinum Toxin Type A
72960-112	DAXXIFY	botulinum toxin type A