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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64067-216		I	Inactivated by FDA		2026-09-09
excluded package	package	64067-216	64067-216-01	I	Inactivated by FDA		2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020969-001	UVADEX	METHOXSALEN	0.02MG/ML	INJECTABLE / INJECTION		RLD, RS	1999-02-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020969-001	UVADEX	0.02MG/ML	INJECTABLE / INJECTION	RLD, RS	1999-02-25	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc0bb075-37ff-40b7-a924-cbc56a34f4df	Product name	2	20150616
15d6fc22-6acb-ed0a-b9b3-e5121820a5aa	Product name	2	20150105
0695936f-2d11-d8f1-b51f-77f23a458cad	Product name	1	20140508
1a8f0cfc-fa3a-e4fd-a79d-5f18408dcc9e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64067-216-01	UVADEX	12 in 1 CARTON	INJECTION, SOLUTION	12		17
64067-216-01	UVADEX	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64067-216-01	ML - Milliliter	64067-216	4cb30eb9-2810-4f70-bec8-3d10798d5751	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Methoxsalen	ACTIVE INGREDIENT	U4VJ29L7BQ	UVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS, INC.]	5
Methoxsalen	ACTIVE MOIETY	U4VJ29L7BQ	UVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64067-216	UVADEX (METHOXSALEN) INJECTION, SOLUTION [THERAKOS LLC]	17	Current NDC, Legacy NDC, 2 package rows	20241220_5ad333bd-845f-43f8-9ecf-43491f26c7c7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U4VJ29L7BQ	METHOXSALEN	298-81-7	METHOXSALEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
282561	methoxsalen 20 MCG/ML Injectable Solution	PSN	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
352083	UVADEX 20 MCG/ML Injectable Solution	PSN	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
352083	methoxsalen 0.02 MG/ML Injectable Solution [Uvadex]	SBD	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
282561	methoxsalen 0.02 MG/ML Injectable Solution	SCD	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
282561	methoxsalen 20 MCG/ML Injectable Solution	SY	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
352083	Uvadex 0.02 MG/ML Injectable Solution	SY	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17
352083	Uvadex 20 MCG/ML Injectable Solution	SY	5ad333bd-845f-43f8-9ecf-43491f26c7c7	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64067-216-01	64067021601	12 VIAL, GLASS in 1 CARTON (64067-216-01) / 10 mL in 1 VIAL, GLASS	1999-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UVADEX ® (Methoxsalen) STERILE SOLUTION, 20 mcg/mL	Therakos LLC	2024-12-16	HUMAN PRESCRIPTION DRUG LABEL	17