VISIONBLUE
VisionBlue® 0.06% Trypan blue Ophthalmic Solution. These highlights do not include all the information needed to use VISIONBLUE® 0.06% safely and effectively. see full prescribing information for VISIONBLUE® 0.06%. VisionBlue® (trypan blue ophthalmic solution) 0.06% Initial U.S. Approval: 2004
Approved
Approval ID
a44bc2ef-3d7f-4125-a7f7-c5969b1b4142
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.
Trypan Blue
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68803-612
Application NumberNDA021670
Product Classification
M
Marketing Category
C73594
G
Generic Name
Trypan Blue
Product Specifications
Route of AdministrationOPHTHALMIC, INTRAOCULAR
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (5)
TRYPAN BLUEActive
Quantity: 0.3 mg in 0.5 mL
Code: I2ZWO3LS3M
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 0.15 mg in 0.5 mL
Code: 5QWK665956
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 0.85 mg in 0.5 mL
Code: 94255I6E2T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.1 mg in 0.5 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Quantity: 0.5 mL in 0.5 mL
Code: 059QF0KO0R
Classification: IACT