Home NDC 10511-3001-2 Cysview
Product NDC 10511-3001
Requested package NDC 10511-3001-2
11-digit product format 105113001
Labeler code 10511
Product ID 10511-3001_49603d9a-adbb-4f38-a35f-d4e969c92a79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hexaminolevulinate hydrochloride
Dosage form KIT
Labeler Photocure Inc.
Application NDA022555
Marketing category NDA
Marketing start 2018-05-01
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022555-001 CYSVIEW KIT HEXAMINOLEVULINATE HYDROCHLORIDE 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022555-001 10556010 2036-12-19 U-2250 2020-03-10 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 N022555-001 11235168 2038-01-04 U-2250 2022-02-15
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022555-001 CYSVIEW KIT 100MG/VIAL FOR SOLUTION / INTRAVESICAL RLD, RS 2010-05-28 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 115 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022555-001 11311620 2036-12-19 U-2250 2022-05-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022555-001 11235168 2038-01-04 U-2250 2022-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022555-001 10556010 2036-12-19 U-2250 2020-03-10 301d65b070ca…
Observed Orange Book exclusivity history# 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 Cysview
Listing expiration 2027-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10511-3001-2 Cysview 1 in 1 CARTON KIT 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10511-3001 CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.] 10 Current NDC, Legacy NDC, 1 package rows 20241105_5aeed40d-6841-4adf-8940-f51d439fdfa3.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10511-3001-2 10511300102 1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS 1 kit 2018-05-01 0000-00-00 No No Current