Valganciclovir Powder, For Solution
NDC Package 71921-210-12

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

Package Information

Valganciclovir 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 Florida Pharmaceutical Products, Llc, this product is identified by NDC 71921-210 and is authorized under FDA application ANDA216317.

Identification & Billing

NDC Package Code
71921-210-12
Package Description
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code
71921-210
11-Digit Billing Format
71921021012
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
Substance Name
Valganciclovir
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 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
Florida Pharmaceutical Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216317
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2023
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 71921-210-12 identifies a specific commercial package of 1 bottle in 1 carton / 100 ml in 1 bottle of Valganciclovir, a human prescription drug labeled by Florida Pharmaceutical Products, Llc. This powder, for solution is formulated for oral use and contains valganciclovir 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 Florida Pharmaceutical Products, Llc on July 01, 2023. The current certification is valid through December 31, 2026.

How is this Florida Pharmaceutical Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71921021012. 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)
71921-210-12
11-Digit CMS (5-4-2)
71921-0210-12

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