Valganciclovir Hydrochloride For Oral Powder, For Solution
NDC Package 42291-972-01

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

Package Information

Valganciclovir Hydrochloride For Oral (valganciclovir hydrochloride) powders 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 powder, for solution delivery system. Marketed by Avkare, this product is identified by NDC 42291-972 and is authorized under FDA application ANDA205220.

Identification & Billing

NDC Package Code
42291-972-01
Package Description
100 mL in 1 BOTTLE
Product Code
42291-972
11-Digit Billing Format
42291097201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valganciclovir Hydrochloride For Oral
Non-Proprietary Name
Valganciclovir Hydrochloride
Substance Name
Valganciclovir Hydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
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
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA205220
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-17-2023
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 42291-972-01 identifies a specific commercial package of 100 ml in 1 bottle of Valganciclovir Hydrochloride For Oral, a human prescription drug labeled by Avkare. This powder, 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 Avkare on October 17, 2023. The current certification is valid through December 31, 2027.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291097201. 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)
42291-972-01
11-Digit CMS (5-4-2)
42291-0972-01

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