FDA.reportPublic FDA data

UVADEX

Product NDC
64067-216
11-digit product format
640670216
Labeler code
64067
Product ID
64067-216_ae164681-3533-4dde-adc2-7b35af9c4f6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methoxsalen
Dosage form
INJECTION, SOLUTION
Route
EXTRACORPOREAL
Labeler
Therakos LLC
Application
NDA020969
Marketing category
NDA
Marketing start
1999-02-25
Substance
METHOXSALEN
Active strength
20 ug/mL
Pharmacologic classes
Photoabsorption [MoA], Photoactivated Radical Generator [EPC], Photosensitizing Activity [PE], Psoralen [EPC], Psoralens [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UVADEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOXSALEN20 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU4VJ29L7BQ
Rxcui282561, 352083

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc0bb075-37ff-40b7-a924-cbc56a34f4dfProduct name220150616
15d6fc22-6acb-ed0a-b9b3-e5121820a5aaProduct name220150105
0695936f-2d11-d8f1-b51f-77f23a458cadProduct name120140508
1a8f0cfc-fa3a-e4fd-a79d-5f18408dcc9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64067-216-01UVADEX12 in 1 CARTONINJECTION, SOLUTION1217
64067-216-01UVADEX10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64067-216-01ML - Milliliter64067-2164cb30eb9-2810-4f70-bec8-3d10798d575112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethoxsalenACTIVE INGREDIENTU4VJ29L7BQUVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS, INC.]5
MethoxsalenACTIVE MOIETYU4VJ29L7BQUVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64067-216UVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS LLC]17Current NDC, Legacy NDC, 2 package rows20241220_5ad333bd-845f-43f8-9ecf-43491f26c7c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282561methoxsalen 20 MCG/ML Injectable SolutionPSN5ad333bd-845f-43f8-9ecf-43491f26c7c717
352083UVADEX 20 MCG/ML Injectable SolutionPSN5ad333bd-845f-43f8-9ecf-43491f26c7c717
352083methoxsalen 0.02 MG/ML Injectable Solution [Uvadex]SBD5ad333bd-845f-43f8-9ecf-43491f26c7c717
282561methoxsalen 0.02 MG/ML Injectable SolutionSCD5ad333bd-845f-43f8-9ecf-43491f26c7c717
282561methoxsalen 20 MCG/ML Injectable SolutionSY5ad333bd-845f-43f8-9ecf-43491f26c7c717
352083Uvadex 0.02 MG/ML Injectable SolutionSY5ad333bd-845f-43f8-9ecf-43491f26c7c717
352083Uvadex 20 MCG/ML Injectable SolutionSY5ad333bd-845f-43f8-9ecf-43491f26c7c717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64067-216-016406702160112 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS1999-02-250000-00-00NoNoCurrent