FDA.reportPublic FDA data

VISIONBLUE

Product NDC
68803-612
11-digit product format
688030612
Labeler code
68803
Product ID
68803-612_4fa726e6-84c6-0f28-e063-6294a90aafe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trypan Blue
Dosage form
INJECTION, SOLUTION
Route
INTRAOCULAR; OPHTHALMIC
Labeler
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Application
NDA021670
Marketing category
NDA
Marketing start
2004-12-16
Substance
TRYPAN BLUE
Active strength
.3 mg/.5mL
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VISIONBLUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRYPAN BLUE.3 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI2ZWO3LS3M

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68803-612-102020-10-08C16284748780-19d75b9d0-1525-f424-e053-dadaa90a57ceVisionBlue® 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), for intraocular ophthalmic use. Initial U.S. Approval: 2004
68803-612-102020-01-31C16284748780-19d75b9d0-1525-f424-e053-dadaa90a57ceVisionBlue® 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), for intraocular ophthalmic use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68803-612-10VISIONBLUE1 in 1 POUCHINJECTION, SOLUTION123
68803-612-10VISIONBLUE10 in 1 CARTONINJECTION, SOLUTION1023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68803-612VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.]21Current NDC, Legacy NDC, 2 package rows20241017_a44bc2ef-3d7f-4125-a7f7-c5969b1b4142.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68803-612-106880306121010 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS10 pouch2004-12-160000-00-00NoNoCurrent