Photrexa Cross-linking Kit

Product NDC: 25357-025
11-digit product format: 253570025
Labeler code: 25357
Product ID: 25357-025_c945d9a7-2e14-41c7-a209-e537aba21749
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: riboflavin 5-phosphate ophthalmic
Dosage form: KIT
Labeler: Glaukos Corporation
Application: NDA203324
Marketing category: NDA
Marketing start: 2017-09-25
Marketing end: 2029-07-31
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N203324-001	PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA	RIBOFLAVIN 5'-PHOSPHATE SODIUM	EQ 0.146% BASE/ML;EQ 0.146% BASE/ML	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-15

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 2 of 3 · 83 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`e64feba35796…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-001	ODE-116	2023-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-001	ODE-121	2023-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-002	ODE-116	2023-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-002	ODE-121	2023-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203324-001	ODE-116	2023-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-001	ODE-121	2023-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-002	ODE-116	2023-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-002	ODE-121	2023-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203324-001	ODE-116	2023-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-001	ODE-121	2023-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-002	ODE-116	2023-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-002	ODE-121	2023-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203324-001	NP	2019-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-001	ODE-116	2023-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-001	ODE-121	2023-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	NP	2019-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	ODE-116	2023-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	ODE-121	2023-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203324-001	ODE-116	2023-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-001	ODE-121	2023-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-002	ODE-116	2023-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-002	ODE-121	2023-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203324-001	ODE-116	2023-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-001	ODE-121	2023-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	ODE-116	2023-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	ODE-121	2023-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	ODE-116	2023-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	ODE-121	2023-07-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	ODE-116	2023-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	ODE-121	2023-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203324-001	ODE-116	2023-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-001	ODE-121	2023-07-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	ODE-116	2023-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	ODE-121	2023-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203324-001	ODE-116	2023-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-001	ODE-121	2023-07-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	ODE-116	2023-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	ODE-121	2023-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203324-001	ODE-116	2023-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203324-001	ODE-121	2023-07-15	`c0c555d07b60…`

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: Photrexa Cross-linking Kit

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1925825	Internal RxNorm lookup
1925830	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
f82cfe92-1a24-11e3-8ffd-0800200c9a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e6383094-adb3-4e58-af3e-6e58e32b9740	Product name	2	20210330

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
25357-025-03	Photrexa Cross-linking Kit	2 in 1 BOX	KIT	2		23
25357-025-03	Photrexa Cross-linking Kit	1 in 1 POUCH	KIT	1		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25357-025-03	ML - Milliliter	25357-025	1ba1350e-21a6-471d-a10c-99676dd2a9e5	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25357-025	PHOTREXA VISCOUS (RIBOFLAVIN 5-PHOSPHATE IN 20% DEXTRAN OPHTHALMIC) SOLUTION/ DROPS PHOTREXA (RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC) SOLUTION/ DROPS PHOTREXA CROSS-LINKING KIT (RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC) KIT [GLAUKOS CORPORATION]	20	Current NDC, Legacy NDC, 2 package rows	20241212_f82cfe92-1a24-11e3-8ffd-0800200c9a66.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
Photrexa Cross-linking Kit	RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC	Glaukos Corporation	f82cfe92-1a24-11e3-8ffd-0800200c9a66	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203324 application number: NDA203324 ndc (product): 25357-025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1925830	Photrexa 0.146 % Ophthalmic Solution	PSN	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23
1925825	riboflavin 5'-phosphate 0.146 % Ophthalmic Solution	PSN	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23
1925830	riboflavin 5'-phosphate 1.46 MG/ML Ophthalmic Solution [Photrexa]	SBD	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23
1925825	riboflavin 5'-phosphate 1.46 MG/ML Ophthalmic Solution	SCD	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23
1925830	Photrexa 1.46 MG/ML Ophthalmic Solution	SY	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23
1925825	riboflavin 5'-phosphate 0.146 % Ophthalmic Solution	SY	f82cfe92-1a24-11e3-8ffd-0800200c9a66	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25357-025-03	25357002503	2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS	2 pouch	2017-09-25	2029-07-31	No	No	Current