uvadex

Generic: methoxsalen

Labeler: therakos llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name uvadex
Generic Name methoxsalen
Labeler therakos llc
Dosage Form INJECTION, SOLUTION
Routes
EXTRACORPOREAL
Active Ingredients

methoxsalen 20 ug/mL

Manufacturer
Therakos LLC

Identifiers & Regulatory

Product NDC 64067-216
Product ID 64067-216_ae164681-3533-4dde-adc2-7b35af9c4f6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020969
Listing Expiration 2026-12-31
Marketing Start 1999-02-25

Pharmacologic Class

Established (EPC)
photoactivated radical generator [epc] psoralen [epc]
Mechanism of Action
photoabsorption [moa]
Chemical Structure
psoralens [cs]
Physiologic Effect
photosensitizing activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64067216
Hyphenated Format 64067-216

Supplemental Identifiers

RxCUI
282561 352083
UPC
0364067216010
UNII
U4VJ29L7BQ
NUI
N0000010217 N0000175984 N0000009801 N0000175879 M0017973

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name uvadex (source: ndc)
Generic Name methoxsalen (source: ndc)
Application Number NDA020969 (source: ndc)
Routes
EXTRACORPOREAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/mL
source: ndc
Packaging
  • 12 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

methoxsalen (20 ug/mL)

Linked Drug Pages (1)

UVADEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EXTRACORPOREAL"], "spl_id": "ae164681-3533-4dde-adc2-7b35af9c4f6d", "openfda": {"nui": ["N0000010217", "N0000175984", "N0000009801", "N0000175879", "M0017973"], "upc": ["0364067216010"], "unii": ["U4VJ29L7BQ"], "rxcui": ["282561", "352083"], "spl_set_id": ["5ad333bd-845f-43f8-9ecf-43491f26c7c7"], "pharm_class_cs": ["Psoralens [CS]"], "pharm_class_pe": ["Photosensitizing Activity [PE]"], "pharm_class_epc": ["Photoactivated Radical Generator [EPC]", "Psoralen [EPC]"], "pharm_class_moa": ["Photoabsorption [MoA]"], "manufacturer_name": ["Therakos LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL, GLASS in 1 CARTON (64067-216-01)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "64067-216-01", "marketing_start_date": "19990225"}], "brand_name": "UVADEX", "product_id": "64067-216_ae164681-3533-4dde-adc2-7b35af9c4f6d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Photoabsorption [MoA]", "Photoactivated Radical Generator [EPC]", "Photosensitizing Activity [PE]", "Psoralen [EPC]", "Psoralens [CS]"], "product_ndc": "64067-216", "generic_name": "Methoxsalen", "labeler_name": "Therakos LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UVADEX", "active_ingredients": [{"name": "METHOXSALEN", "strength": "20 ug/mL"}], "application_number": "NDA020969", "marketing_category": "NDA", "marketing_start_date": "19990225", "listing_expiration_date": "20261231"}