Valganciclovir For Solution
NDC Package 71151-003-01

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

Package Information

Valganciclovir for solutions is treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1)]. This formulation utilizes a for solution delivery system. Marketed by Airis Pharma Pvt Ltd, this product is identified by NDC 71151-003 and is authorized under FDA application ANDA210169.

Identification & Billing

NDC Package Code
71151-003-01
Package Description
100 mL in 1 BOTTLE, DISPENSING
Product Code
71151-003
11-Digit Billing Format
71151000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valganciclovir
Non-Proprietary Name
Valganciclovir
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
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir for oral solution is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1)] . Prevention of CMV Disease: Valganciclovir for oral solution is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies ( 14.1)] .

Regulatory & Marketing

Labeler Name
Airis Pharma Pvt Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA210169
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71151-003-01 identifies a specific commercial package of 100 ml in 1 bottle, dispensing of Valganciclovir, a human prescription drug labeled by Airis Pharma Pvt Ltd. 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 Airis Pharma Pvt Ltd on February 28, 2022. The current certification is valid through December 31, 2026.

How is this Airis Pharma Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71151000301. 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)
71151-003-01
11-Digit CMS (5-4-2)
71151-0003-01

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