Cytalux
- Product NDC
- 81052-138
- 11-digit product format
- 810520138
- Labeler code
- 81052
- Product ID
- 81052-138_4cc23694-63af-f9f1-e063-6394a90a4ce0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pafolacianine injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- On Target Laboratories, Inc.
- Application
- NDA214907
- Marketing category
- NDA
- Marketing start
- 2021-11-29
- Substance
- PAFOLACIANINE SODIUM
- Active strength
- 3.2 mg/1.6mL
- Pharmacologic classes
- Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cytalux
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAFOLACIANINE SODIUM | 3.2 mg/1.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4HUF3V875C |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81052-138-01 | Cytalux | 1.6 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1.6 | | 10 |
| 81052-138-10 | Cytalux | 10 in 1 CARTON | INJECTION | 10 | | 10 |
| 81052-138-10 | Cytalux | 1 in 1 CARTON | INJECTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81052-138 | CYTALUX (PAFOLACIANINE INJECTION) INJECTION [ON TARGET LABORATORIES, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241016_d21952b9-7c4e-3a56-e053-2a95a90a0ab0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81052-138-01 | 81052013801 | 1.6 mL in 1 VIAL, SINGLE-DOSE | 1.6 ml | | | | | Historical |
| 81052-138-10 | 81052013810 | 10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01) | 10 carton | 2021-11-29 | 0000-00-00 | No | No | Current |