Visudyne

Product NDC
24208-560
11-digit product format
242080560
Labeler code
24208
Product ID
24208-560_f48ec619-2eda-4360-9c67-bb79bdd00353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verteporfin for injection
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bausch & Lomb Incorporated
Application
NDA021119
Marketing category
NDA
Marketing start
2000-04-12
Substance
VERTEPORFIN
Active strength
15 mg/1
Pharmacologic classes
Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021119-001VISUDYNEVERTEPORFIN15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1284e616aacf4f…
2026-08-18 06:07:402026-07N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021119-001VISUDYNE15MG/VIALINJECTABLE / INJECTIONRLD, RS2000-04-12f41ea6bd6efb…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERTEPORFIN15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0X9PA28K43Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f0a34ce-3c57-4ac8-b28e-512be807272fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-560-15Visudyne1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-560-15EA - Each24208-56007cc4c25-1628-4e0d-becd-c1ca320fbefd12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-560VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAUSCH & LOMB INCORPORATED]5Current NDC, 1 package rows20230603_2f0a34ce-3c57-4ac8-b28e-512be807272f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VisudyneVERTEPORFIN FOR INJECTIONBausch Health US LLC952f4c80-50b1-4308-9ee6-311ffefb13df2025-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021119
application number: NDA021119
VisudyneVERTEPORFIN FOR INJECTIONBausch & Lomb Incorporated2f0a34ce-3c57-4ac8-b28e-512be807272f2023-02-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 021119
application number: NDA021119
ndc (product): 24208-560

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313595verteporfin 15 MG InjectionPSN2f0a34ce-3c57-4ac8-b28e-512be807272f5
351914Visudyne 15 MG InjectionPSN2f0a34ce-3c57-4ac8-b28e-512be807272f5
351914verteporfin 15 MG Injection [Visudyne]SBD2f0a34ce-3c57-4ac8-b28e-512be807272f5
313595verteporfin 15 MG InjectionSCD2f0a34ce-3c57-4ac8-b28e-512be807272f5
351914Visudyne 15 MG InjectionSY2f0a34ce-3c57-4ac8-b28e-512be807272f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24208-560-15242080560151 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (24208-560-15) 2023-02-27NoNoCurrent