NDC 64067-216

UVADEX

Methoxsalen

UVADEX is a Extracorporeal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Therakos, Inc.. The primary component is Methoxsalen.

• Product ID: 64067-216_6c5b68f2-b4b9-434b-9036-22d1b37bf68b
• NDC: 64067-216
• Product Type: Human Prescription Drug
• Proprietary Name: UVADEX
• Generic Name: Methoxsalen
• Dosage Form: Injection, Solution
• Route of Administration: EXTRACORPOREAL
• Marketing Start Date: 1999-02-25
• Marketing Category: NDA / NDA
• Application Number: NDA020969
• Labeler Name: Therakos, Inc.
• Substance Name: METHOXSALEN
• Active Ingredient Strength: 20 ug/mL
• Pharm Classes: Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 64067-216-01

12 VIAL, GLASS in 1 CARTON (64067-216-01) > 10 mL in 1 VIAL, GLASS

• Marketing Start Date: 1999-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64067-216-01 [64067021601]

UVADEX INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020969
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-02-25

Drug Details

Active Ingredients

Ingredient	Strength
METHOXSALEN	20 ug/mL

OpenFDA Data

• SPL SET ID: 5ad333bd-845f-43f8-9ecf-43491f26c7c7
• Manufacturer:
  • Therakos, Inc.
• UNII:
  • U4VJ29L7BQ
• RxNorm Concept Unique ID - RxCUI:
  • 282561
  • 352083

Pharmacological Class

• Psoralen [EPC]
• Psoralens [CS]
• Photoabsorption [MoA]
• Photoactivated Radical Generator [EPC]
• Photosensitizing Activity [PE]

NDC Crossover Matching brand name "UVADEX" or generic name "Methoxsalen"

NDC	Brand Name	Generic Name
64067-216	UVADEX	Methoxsalen
45963-325	Methoxsalen	Methoxsalen
64380-752	Methoxsalen	Methoxsalen
68682-065	Methoxsalen	Methoxsalen
0187-0650	Oxsoralen-Ultra	Methoxsalen