Visudyne

Product NDC: 0187-5600
Requested package NDC: 0187-5600-15
11-digit product format: 001875600
Labeler code: 0187
Product ID: 0187-5600_3d5b1ecb-4d6e-8696-e063-6394a90adf2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: verteporfin for injection
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Bausch Health US LLC
Application: NDA021119
Marketing category: NDA
Marketing start: 2000-04-12
Marketing end: 2027-12-01
Substance: VERTEPORFIN
Active strength: 15 mg/1
Pharmacologic classes: Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021119-001	VISUDYNE	VERTEPORFIN	15MG/VIAL	INJECTABLE / INJECTION		RLD, RS	2000-04-12

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021119-001	VISUDYNE	15MG/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-04-12	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Visudyne

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VERTEPORFIN	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0X9PA28K43	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313595	Internal RxNorm lookup
351914	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
952f4c80-50b1-4308-9ee6-311ffefb13df	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-5600-15	2025-08-21	C162847	48780-1	3b156c62-33c8-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use VISUDYNE safely and effectively. See full prescribing information for VISUDYNE. VISUDYNE ® (verteporfin for injection), for intravenous use Initial U.S. Approval: 2000
0187-5600-15	2025-07-29	C162847	48780-1	3b156c62-33c8-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use VISUDYNE safely and effectively. See full prescribing information for VISUDYNE. VISUDYNE ® (verteporfin for injection), for intravenous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-5600-15	Visudyne	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VERTEPORFIN	ACTIVE INGREDIENT	0X9PA28K43	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
VERTEPORFIN	ACTIVE MOIETY	0X9PA28K43	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5600	VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAUSCH HEALTH US LLC]	13	Current NDC, Legacy NDC, 1 package rows	20220506_952f4c80-50b1-4308-9ee6-311ffefb13df.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Visudyne	VERTEPORFIN FOR INJECTION	Bausch Health US LLC	952f4c80-50b1-4308-9ee6-311ffefb13df	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021119 application number: NDA021119 ndc (package): 0187-5600-15 ndc (product): 0187-5600 ndc11 (package): 00187560015
Visudyne	VERTEPORFIN FOR INJECTION	Bausch & Lomb Incorporated	2f0a34ce-3c57-4ac8-b28e-512be807272f	2023-02-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021119 application number: NDA021119

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0X9PA28K43	VERTEPORFIN	129497-78-5	VERTEPORFIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313595	verteporfin 15 MG Injection	PSN	952f4c80-50b1-4308-9ee6-311ffefb13df	15
351914	Visudyne 15 MG Injection	PSN	952f4c80-50b1-4308-9ee6-311ffefb13df	15
351914	verteporfin 15 MG Injection [Visudyne]	SBD	952f4c80-50b1-4308-9ee6-311ffefb13df	15
313595	verteporfin 15 MG Injection	SCD	952f4c80-50b1-4308-9ee6-311ffefb13df	15
351914	Visudyne 15 MG Injection	SY	952f4c80-50b1-4308-9ee6-311ffefb13df	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5600-15	00187560015	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0187-5600-15)	2000-04-12	2027-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
verteporfin for injection	Bausch Health US LLC \| Alcami Carolinas Corporation	2025-08-27	HUMAN PRESCRIPTION DRUG LABEL	15