NDC 50236-001

Visudyne

Verteporfin For Injection

Visudyne is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Qlt Ophthalmics, Inc.. The primary component is Verteporfin.

• Product ID: 50236-001_41e7889e-a183-4fea-9e12-63052f878cc0
• NDC: 50236-001
• Product Type: Human Prescription Drug
• Proprietary Name: Visudyne
• Generic Name: Verteporfin For Injection
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2000-04-12
• Marketing Category: NDA / NDA
• Application Number: NDA021119
• Labeler Name: QLT Ophthalmics, Inc.
• Substance Name: VERTEPORFIN
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 50236-001-15

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (50236-001-15)

• Marketing Start Date: 2000-04-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50236-001-15 [50236000115]

Visudyne INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021119
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-04-12
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
VERTEPORFIN	15 mg/1

OpenFDA Data

• SPL SET ID: 31512723-9ff0-4e18-aa3a-55ab833038c6
• Manufacturer:
  • QLT Ophthalmics, Inc.
• UNII:
  • 0X9PA28K43
• RxNorm Concept Unique ID - RxCUI:
  • 351914
  • 313595

Pharmacological Class

• Photoabsorption [MoA]
• Photoenhancer [EPC]
• Photosensitizing Activity [PE]

NDC Crossover Matching brand name "Visudyne" or generic name "Verteporfin For Injection"

NDC	Brand Name	Generic Name
0187-5600	Visudyne	verteporfin for injection
50236-001	Visudyne	verteporfin for injection