TISSUEBLUE
TissueBlue: These highlights do not include all the information needed to use TissueBlue 0.025% safely and effectively. See full prescribing information for TissueBlue 0.025%. Initial U.S. Approval: 2019
Approved
Approval ID
9d4b28b4-c582-4e2c-abd9-f7e203378e2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
DUNS: 407522184
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brilliant Blue G
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68803-722
Application NumberNDA209569
Product Classification
M
Marketing Category
C73594
G
Generic Name
Brilliant Blue G
Product Specifications
Route of AdministrationINTRAOCULAR, OPHTHALMIC
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 8.2 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Quantity: 3.1 mg in 0.5 mL
Code: E1W4N241FO
Classification: IACT
WATERInactive
Quantity: 4743 g in 0.5 mL
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 0.3 mg in 0.5 mL
Code: 5QWK665956
Classification: IACT
BRILLIANT BLUE GActive
Quantity: 0.0125 mg in 0.5 mL
Code: M1ZRX790SI
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 2 mg in 0.5 mL
Code: G2M7P15E5P
Classification: IACT