TISSUEBLUE
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- TISSUEBLUE
- Generic name
- BRILLIANT BLUE G
- Manufacturer
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 9d4b28b4-c582-4e2c-abd9-f7e203378e2d
- SPL ID
- 4fa75b7a-9ebf-72e1-e063-6294a90a2565
- Version
- 8
- Effective date
- 2026-04-17
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:11
| Harmonized routes |
|---|
| INTRAOCULAR, OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 209569 | derived:openfda.application_number |
| application number | NDA209569 | openfda.application_number | |
| brand name | TISSUEBLUE | openfda.brand_name | |
| generic name | BRILLIANT BLUE G | openfda.generic_name | |
| manufacturer name | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | openfda.manufacturer_name | |
| ndc | package | 68803-722-05 | openfda.package_ndc |
| ndc | product | 68803-722 | openfda.product_ndc |
| ndc11 | package | 68803072205 | derived:openfda.package_ndc |
| spl id | 4fa75b7a-9ebf-72e1-e063-6294a90a2565 | id | |
| spl set id | 9d4b28b4-c582-4e2c-abd9-f7e203378e2d | set_id | |
| unii | M1ZRX790SI | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings and Precautions Excessive Staining Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the Syringe Make sure the plunger moves smoothly before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula. Excessive staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the syringe: Make sure the plunger moves smoothly before injecting the solution.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. To report SUSPECTED ADVERSE REACTIONS, contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.