Home NDC 68803-612 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 68803-612 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68803-612 68803-612-10 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021670-001 VISIONBLUE TRYPAN BLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021670-001 VISIONBLUE 0.06% SOLUTION / OPHTHALMIC RLD, RS 2004-12-16 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021670-001 6720314 2019-05-07 U-2321 2018-06-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021670-001 6367480 2019-10-26 U-2321 2018-06-21 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021670-001 6720314 2019-05-07 U-2321 2018-06-21 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021670-001 6367480 2019-10-26 U-2321 2018-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021670-001 6720314 2019-05-07 U-2321 2018-06-21 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021670-001 6367480 2019-10-26 U-2321 2018-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021670-001 6720314 2019-05-07 U-2321 2018-06-21 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021670-001 6367480 2019-10-26 U-2321 2018-06-21 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base VISIONBLUE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRYPAN BLUE .3 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I2ZWO3LS3M Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68803-612-10 VISIONBLUE 1 in 1 POUCH INJECTION, SOLUTION 1 23 68803-612-10 VISIONBLUE 10 in 1 CARTON INJECTION, SOLUTION 10 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRYPAN BLUE ACTIVE INGREDIENT I2ZWO3LS3M VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4 TRYPAN BLUE ACTIVE MOIETY I2ZWO3LS3M VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4 SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE INACTIVE INGREDIENT 5QWK665956 VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68803-612 VISIONBLUE (TRYPAN BLUE) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.] 21 Current NDC, Legacy NDC, 2 package rows 20241017_a44bc2ef-3d7f-4125-a7f7-c5969b1b4142.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 VISIONBLUE TRYPAN BLUE D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. a44bc2ef-3d7f-4125-a7f7-c5969b1b4142 2026-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 021670 application number: NDA021670 ndc (product): 68803-612
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68803-612-10 68803061210 10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS 10 pouch 2004-12-16 0000-00-00 No No Current