Cysview Kit
NDC Package 10511-3001-2
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
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10511 - Photocure Inc.
- 10511-3001 - Cysview
- 10511-3001-2 - 1 KIT in 1 CARTON * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS
- 10511-3001 - Cysview
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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.
* 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 10511-3001-2 identifies a specific commercial package of 1 kit in 1 carton * 50 ml in 1 syringe, 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: 10511300102. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
