NDC Package 10511-3001-2 Cysview

Hexaminolevulinate Hydrochloride Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10511-3001-2
Package Description:
1 KIT in 1 CARTON * 50 mL in 1 VIAL, GLASS * 50 mL in 1 SYRINGE, PLASTIC
Product Code:
Proprietary Name:
Cysview
Non-Proprietary Name:
Hexaminolevulinate Hydrochloride
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.
11-Digit NDC Billing Format:
10511300102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type:
Human Prescription Drug
Labeler Name:
Photocure Inc.
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
NDA022555
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
05-01-2018
Listing Expiration Date:
12-31-2024
Exclude Flag:
N
Code Structure:

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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 10511-3001-2 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
10511300102A9589Insti hexaminolevulinate hcl100 MG1111

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Frequently Asked Questions

What is NDC 10511-3001-2?

The NDC Packaged Code 10511-3001-2 is assigned to a package of 1 kit in 1 carton * 50 ml in 1 vial, glass * 50 ml in 1 syringe, plastic of Cysview, a human prescription drug labeled by Photocure Inc.. The product's dosage form is kit and is administered via form.

Is NDC 10511-3001 included in the NDC Directory?

Yes, Cysview with product code 10511-3001 is active and included in the NDC Directory. The product was first marketed by Photocure Inc. on May 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 10511-3001-2?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 10511-3001-2?

The 11-digit format is 10511300102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-110511-3001-25-4-210511-3001-02