NDC 60923-465

Vyondys 53

Golodirsen

Vyondys 53 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sarepta Therapeutics, Inc.. The primary component is Golodirsen.

• Product ID: 60923-465_0087bc28-15bf-4790-a385-f1cc6009a60d
• NDC: 60923-465
• Product Type: Human Prescription Drug
• Proprietary Name: Vyondys 53
• Generic Name: Golodirsen
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-12-12
• Marketing Category: NDA / NDA
• Application Number: NDA211970
• Labeler Name: Sarepta Therapeutics, Inc.
• Substance Name: GOLODIRSEN
• Active Ingredient Strength: 50 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 60923-465-02

1 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) > 2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-12-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60923-465-02 [60923046502]

Vyondys 53 INJECTION

• Marketing Category: NDA
• Application Number: NDA211970
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-12

Drug Details

Active Ingredients

Ingredient	Strength
GOLODIRSEN	50 mg/mL

OpenFDA Data

• SPL SET ID: 35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5
• Manufacturer:
  • Sarepta Therapeutics, Inc.
• UNII:
  • 033072U4MZ
• RxNorm Concept Unique ID - RxCUI:
  • 2267211
  • 2267216
• UPC Code:
  • 0360923465028