Cysview Kit
NDC Package 10511-3001-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cysview (hexaminolevulinate hydrochloride) kits is cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. This formulation utilizes a kit delivery system. Marketed by Photocure Inc., this product is identified by NDC 10511-3001 and is authorized under FDA application NDA022555.

Identification & Billing

NDC Package Code
10511-3001-1
Package Description
1 KIT in 1 CARTON * 50 mL in 1 VIAL, PLASTIC * 50 mL in 1 VIAL, GLASS
Product Code
10511-3001
11-Digit Billing Format
10511300101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Cysview
Non-Proprietary Name
Hexaminolevulinate Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC™) as an adjunct to the white light cystoscopy.

Regulatory & Marketing

Labeler Name
Photocure Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022555
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10511-3001). Click a package code to view its specific billing and regulatory data.

10511-3001-2
1 KIT in 1 CARTON * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10511-3001-1 identifies a specific commercial package of 1 kit in 1 carton * 50 ml in 1 vial, plastic * 50 ml in 1 vial, glass of Cysview, a human prescription drug labeled by Photocure Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Photocure Inc. on May 01, 2018. The current certification is valid through December 31, 2027.

How is this Photocure Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10511300101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
10511-3001-1
11-Digit CMS (5-4-2)
10511-3001-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.