Prescription drug · NDA
Cytalux (Pafolacianine injection) NDC 81052-138
Pafolacianine sodium 3.2 mg/1.6mL · Injection · Intravenous · On Target Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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)Marketed from Nov 29, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cytalux
- Generic name (nonproprietary)
- pafolacianine injection
- Active ingredients
- Pafolacianine sodium — 3.2 mg/1.6mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- On Target Laboratories, Inc.NDC labeler code 81052
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214907
- Marketing start
- Listing expires
- Other FDA classes
- Fluorescence Contrast Activity (Mechanism)
- Identifiers
- Product ID 81052-138_4cc23694-63af-f9f1-e063-6394a90a4ce0SPL ID 4cc23694-63af-f9f1-e063-6394a90a4ce0SPL set ID d21952b9-7c4e-3a56-e053-2a95a90a0ab0UNII 4HUF3V875C
- Pharmacologic class
- Optical Imaging Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481052013810followed by a unit qualifier and the quantityPackage 81052-0138-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81052-138
- What is NDC 81052-138?
- 81052-138 is the product NDC for Cytalux (pafolacianine injection), Pafolacianine sodium 3.2 mg/1.6mL injection, listed with the FDA by On Target Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cytalux (Pafolacianine injection).
- What is the active ingredient?
- Pafolacianine sodium.
- Who is the labeler?
- On Target Laboratories, Inc., NDC labeler code 81052. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cytalux?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.