TISSUEBLUE
- Product NDC
- 68803-722
- 11-digit product format
- 688030722
- Labeler code
- 68803
- Product ID
- 68803-722_4fa75b7a-9ebf-72e1-e063-6294a90a2565
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brilliant Blue G
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAOCULAR; OPHTHALMIC
- Labeler
- D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Application
- NDA209569
- Marketing category
- NDA
- Marketing start
- 2019-12-31
- Substance
- BRILLIANT BLUE G
- Active strength
- .0125 mg/.5mL
- Pharmacologic classes
- Disclosing Agent [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
- TISSUEBLUE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRILLIANT BLUE G | .0125 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M1ZRX790SI |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68803-722-05 | TISSUEBLUE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 8 |
| 68803-722-05 | TISSUEBLUE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68803-722 | TISSUEBLUE (BRILLIANT BLUE G) INJECTION, SOLUTION [D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231006_9d4b28b4-c582-4e2c-abd9-f7e203378e2d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68803-722-05 | 68803072205 | 10 POUCH in 1 CARTON (68803-722-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS | 10 pouch | 2019-12-31 | 0000-00-00 | No | No | Current |