NDC 0299-5962

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 Galderma Laboratories, L.p.. The primary component is Botulinum Toxin Type A.

• Product ID: 0299-5962_20b6057c-47dc-489c-b8c9-acb8409dac60
• NDC: 0299-5962
• 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: Galderma Laboratories, L.P.
• Substance Name: BOTULINUM TOXIN TYPE A
• Active Ingredient Strength: 300 U/1
• Pharm Classes: Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0299-5962-01

1 VIAL in 1 CARTON (0299-5962-01) > 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 0299-5962-01 [00299596201]

Dysport INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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

NDC 0299-5962-30 [00299596230]

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

Drug Details

Active Ingredients

Ingredient	Strength
BOTULINUM TOXIN TYPE A	300 U/1

OpenFDA Data

• SPL SET ID: 71313a04-1349-4c26-b840-a39e4a3ddaed
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • E211KPY694
• RxNorm Concept Unique ID - RxCUI:
  • 1789958
  • 1789956

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