Valrubicin Intravesical Solution Solution, Concentrate
NDC Package 24201-101-04

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

Package Information

Valrubicin Intravesical Solution solution is valrubicin is used to treat bladder cancer. This formulation utilizes a solution, concentrate delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 24201-101 and is authorized under FDA application ANDA206430.

Identification & Billing

NDC Package Code
24201-101-04
Package Description
4 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
24201-101
11-Digit Billing Format
24201010104
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313567 - valrubicin 200 MG in 5 mL (40 MG/mL) Intravesical Solution
  • RxCUI: 313567 - valrubicin 40 MG/ML Intravesical Solution
  • RxCUI: 313567 - valrubicin 200 MG per 5 ML Intravesical Solution

Clinical Specifications

Proprietary Name
Valrubicin Intravesical Solution
Non-Proprietary Name
Valrubicin Intravesical Solution
Substance Name
Valrubicin
Dosage Form
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route
Intravesical - Administration within the bladder.
Active Ingredient(s)
VALRUBICIN 40 mg/mL
Usage Information
Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment. This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206430
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2019
Listing Expiration
12-31-2026
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.

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.

J9357
Source: ASP
Valrubicin injection
HCPCS Dosage 200 MG
Units / Pkg 4

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 24201-101-04 identifies a specific commercial package of 4 vial in 1 carton / 5 ml in 1 vial of Valrubicin Intravesical Solution, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This solution, concentrate is formulated for intravesical use and contains valrubicin 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 Hikma Pharmaceuticals Usa Inc. on April 23, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment. This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24201010104. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
24201-101-04
11-Digit CMS (5-4-2)
24201-0101-04

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