Cysview Kit
NDC 10511-3001

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 10511-3001?
  4. Cysview Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

Cysview (hexaminolevulinate hydrochloride) is a NDA-approved product labeled by Photocure Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 10511-3001 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
10511-3001
Proprietary Name:
Cysview
Non-Proprietary Name: [1]
Hexaminolevulinate Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Photocure Inc.
Labeler Code:
10511
Product Label ID:
5aeed40d-6841-4adf-8940-f51d439fdfa3
FDA Application Number: [6]
NDA022555
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-01-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 10511-3001?

The NDC code 10511-3001 is assigned by the FDA to the product Cysview. It is commonly known by its generic name, hexaminolevulinate hydrochloride. This pharmaceutical product is labeled by Photocure Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 10511-3001-1, 10511-3001-2. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • HEXAMINOLEVULINATE HYDROCHLORIDE (UNII: D4F329SL1O)
  • HEXAMINOLEVULINATE (UNII: G7H20TKI67) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".