Valganciclovir For Solution
NDC Package 59651-444-01

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

Package Information

Valganciclovir (valganciclovir hydrochloride powder,) for solutions is valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions (6.1)]. This formulation utilizes a for solution delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 59651-444 and is authorized under FDA application ANDA215124.

Identification & Billing

NDC Package Code
59651-444-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS
Product Code
59651-444
11-Digit Billing Format
59651044401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valganciclovir
Non-Proprietary Name
Valganciclovir Hydrochloride Powder,
Substance Name
Valganciclovir Hydrochloride
Dosage Form
For Solution - A product, usually a solid, intended for solution prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL
Pharmacologic Class
Usage Information
Valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions (6.1)].

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215124
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59651-444-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass of Valganciclovir, a human prescription drug labeled by Aurobindo Pharma Limited. This for solution is formulated for oral use and contains valganciclovir hydrochloride 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 Aurobindo Pharma Limited on November 17, 2022. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59651044401. 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)
59651-444-01
11-Digit CMS (5-4-2)
59651-0444-01

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