LUMISIGHT
- Product NDC
- 82292-040
- 11-digit product format
- 822920040
- Labeler code
- 82292
- Product ID
- 82292-040_8a6aec36-4e75-4cd0-a250-cb126128bbd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pegulicianine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Lumicell, Inc.
- Application
- NDA214511
- Marketing category
- NDA
- Marketing start
- 2024-04-17
- Substance
- PEGULICIANINE
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUMISIGHT
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEGULICIANINE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T6HE85WN0Q |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82292-040-01 | LUMISIGHT | 3.9 mL in 1 VIAL | Injection, powder, lyophilized, | 3.9 | | 3 |
| 82292-040-10 | LUMISIGHT | 10 in 1 CARTON | Injection, powder, lyophilized, | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82292-040 | LUMISIGHT (PEGULICIANINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LUMICELL, INC.] | 2 | Current NDC, 2 package rows | 20240605_7160e774-663a-43e4-ba4a-06cc57830e66.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82292-040-01 | 82292004001 | 3.9 mL in 1 VIAL | 3.9 ml | | | | Historical |
| 82292-040-10 | 82292004010 | 10 VIAL in 1 CARTON (82292-040-10) / 3.9 mL in 1 VIAL (82292-040-01) | 10 vial | 2024-04-17 | No | No | Historical |