Cysview

Product NDC: 10511-3001
11-digit product format: 105113001
Labeler code: 10511
Product ID: 10511-3001_45327ab1-894f-2a0d-e063-6294a90ab95e
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: 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	10511-3001		D	Discontinued by firm		2026-08-17
excluded package	package	10511-3001	10511-3001-1	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10511-3001-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10511-3001-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10511-3001-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10511-3001-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10511-3001-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10511-3001-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10511-3001-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10511-3001-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10511-3001-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10511-3001-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10511-3001-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10511-3001-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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	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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022555-001	M-220	2021-02-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022555-001	M-220	2021-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022555-001	M-220	2021-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022555-001	M-220	2021-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022555-001	M-220	2021-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022555-001	M-220	2021-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022555-001	M-220	2021-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022555-001	M-220	2021-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022555-001	M-220	2021-02-15	`ea99ee380514…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5aeed40d-6841-4adf-8940-f51d439fdfa3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
a519d6dc-1441-46c8-94a2-f91fb5b16296	Product name	1	20180510

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10511-3001-1	EA - Each	10511-3001	2c154b2a-b5d3-4351-8265-60eff805b83f	1	2015-10-02
10511-3001-2	EA - Each	10511-3001	ec545a0a-4e89-4624-8bbe-0eec0e80bbf3	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
hexaminolevulinate hydrochloride	ACTIVE INGREDIENT	D4F329SL1O	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
hexaminolevulinate	ACTIVE MOIETY	G7H20TKI67	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
potassium phosphate, monobasic	INACTIVE INGREDIENT	4J9FJ0HL51	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	CYSVIEW (HEXAMINOLEVULINATE HYDROCHLORIDE) KIT [PHOTOCURE INC.]	2

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cysview	HEXAMINOLEVULINATE HYDROCHLORIDE	Photocure Inc.	5aeed40d-6841-4adf-8940-f51d439fdfa3	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022555 application number: NDA022555 ndc (product): 10511-3001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D4F329SL1O	HEXAMINOLEVULINATE HYDROCHLORIDE	140898-91-5	Hexaminolevulinate hydrochloride

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cysview	Photocure Inc.	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	12
Cysview	Photocure Inc \| Orifice Medical AB	2018-12-04	HUMAN PRESCRIPTION DRUG LABEL	6