MEMBRANEBLUE

Product NDC: 68803-672
Requested package NDC: 68803-672-05
11-digit product format: 688030672
Labeler code: 68803
Product ID: 68803-672_44559f09-e0e2-a332-e063-6394a90aa296
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: trypan blue
Dosage form: INJECTION, SOLUTION
Route: INTRAOCULAR; OPHTHALMIC
Labeler: Dutch Ophthalmic Research Center (International) B.V.
Application: NDA022278
Marketing category: NDA
Marketing start: 2009-02-20
Substance: TRYPAN BLUE
Active strength: .75 mg/.5mL
Pharmacologic classes: Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-06-10 20:45 UTC · source 2020-06-10	`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
N022278-001	MEMBRANEBLUE	TRYPAN BLUE	0.15%	SOLUTION / OPHTHALMIC		RLD	2009-02-20

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD	2009-02-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022278-001	MEMBRANEBLUE	0.15%	SOLUTION / OPHTHALMIC	RLD, RS	2009-02-20	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022278-001	6696430	2019-05-07	U-2377	2018-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022278-001	6372449	2019-11-12	U-2379	2018-09-06	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022278-001	6696430	2019-05-07	U-2377	2018-09-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022278-001	6372449	2019-11-12	U-2379	2018-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022278-001	6696430	2019-05-07	U-2377	2018-09-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022278-001	6372449	2019-11-12	U-2379	2018-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022278-001	6696430	2019-05-07	U-2377	2018-09-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022278-001	6372449	2019-11-12	U-2379	2018-09-06	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: MEMBRANEBLUE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRYPAN BLUE	.75 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0364aceb-dd3f-4bac-b468-25379a07ccfc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-11-24	MembraneBlue™ 0.15% (trypan blue ophthalmic solution). These highlights do not include all the information needed to use MembraneBlue™ 0.15% safely and effectively. See full prescribing information for MembraneBlue™ 0.15%. MembraneBlue™ 0.15% (trypan blue ophthalmic solution) Initial U.S. Approval: 2004
2023-01-30	MembraneBlue™ 0.15% (trypan blue ophthalmic solution). These highlights do not include all the information needed to use MembraneBlue™ 0.15% safely and effectively. See full prescribing information for MembraneBlue™ 0.15%. MembraneBlue™ 0.15% (trypan blue ophthalmic solution) Initial U.S. Approval: 2004
2020-10-08	MembraneBlue™ 0.15% (trypan blue ophthalmic solution). These highlights do not include all the information needed to use MembraneBlue™ 0.15% safely and effectively. See full prescribing information for MembraneBlue™ 0.15%. MembraneBlue™ 0.15% (trypan blue ophthalmic solution) Initial U.S. Approval: 2004
2020-01-31	MembraneBlue™ 0.15% (trypan blue ophthalmic solution). These highlights do not include all the information needed to use MembraneBlue™ 0.15% safely and effectively. See full prescribing information for MembraneBlue™ 0.15%. MembraneBlue™ 0.15% (trypan blue ophthalmic solution) Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68803-672-05	MEMBRANEBLUE	1 in 1 POUCH	INJECTION, SOLUTION	1		17
68803-672-05	MEMBRANEBLUE	5 in 1 CARTON	INJECTION, SOLUTION	5		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68803-672-05	ML - Milliliter	68803-672	98e1aaca-d63e-4a4a-bb64-a24de33bec8c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRYPAN BLUE	ACTIVE INGREDIENT	I2ZWO3LS3M	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5
TRYPAN BLUE	ACTIVE MOIETY	I2ZWO3LS3M	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEMBRANEBLUE (TRYPAN BLUE ) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL B.V.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68803-672	MEMBRANEBLUE (TRYPAN BLUE) INJECTION, SOLUTION [DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.]	16	Current NDC, Legacy NDC, 2 package rows	20211116_0364aceb-dd3f-4bac-b468-25379a07ccfc.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
MEMBRANEBLUE	TRYPAN BLUE	Dutch Ophthalmic Research Center (International) B.V.	0364aceb-dd3f-4bac-b468-25379a07ccfc	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022278 application number: NDA022278 ndc (package): 68803-672-05 ndc (product): 68803-672 ndc11 (package): 68803067205

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I2ZWO3LS3M	TRYPAN BLUE	72-57-1	TRYPAN BLUE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68803-672-05	68803067205	5 POUCH in 1 CARTON (68803-672-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS	5 pouch	2009-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEMBRANEBLUE	Dutch Ophthalmic Research Center (International) B.V. \| Pharmpur GmbH	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	17