Home NDC 68803-722 TISSUEBLUE
Product NDC 68803-722
11-digit product format 688030722
Labeler code 68803
Product ID 68803-722_4fa75b7a-9ebf-72e1-e063-6294a90a2565
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brilliant Blue G
Dosage form INJECTION, SOLUTION
Route INTRAOCULAR; OPHTHALMIC
Labeler D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Application NDA209569
Marketing category NDA
Marketing start 2019-12-31
Substance BRILLIANT BLUE G
Active strength .0125 mg/.5mL
Pharmacologic classes Disclosing Agent [EPC], Dyes [MoA]
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 N209569-001 TISSUEBLUE BRILLIANT BLUE G 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209569-001 ODE-282 2026-12-20
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.
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 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
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 TISSUEBLUE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRILLIANT BLUE G .0125 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M1ZRX790SI Internal UNII lookup
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 68803-722-05 TISSUEBLUE 1 in 1 POUCH INJECTION, SOLUTION 1 8 68803-722-05 TISSUEBLUE 10 in 1 CARTON INJECTION, SOLUTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68803-722 TISSUEBLUE (BRILLIANT BLUE G) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.] 5 Current NDC, Legacy NDC, 2 package rows 20231006_9d4b28b4-c582-4e2c-abd9-f7e203378e2d.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 TISSUEBLUE BRILLIANT BLUE G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. 9d4b28b4-c582-4e2c-abd9-f7e203378e2d 2026-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 209569 application number: NDA209569 ndc (product): 68803-722
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68803-722-05 68803072205 10 POUCH in 1 CARTON (68803-722-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS 10 pouch 2019-12-31 0000-00-00 No No Current