FDA label
What is valganciclovir used for?
The FDA-approved uses of valganciclovir, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for valganciclovir (tablet, film coated) lists 2 uses: Adult Patients; Pediatric Patients.
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Valganciclovir, tablet, film coated
Indications and Usage, quoted from the label by Dr. Reddy's Laboratories Limited (ANDA203511). Cross-references to other label sections are left out.
Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis:
Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV Disease:
Valganciclovir tablets are 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-]).
Pediatric Patients
Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Source: DailyMed label, set id f37c0780-b953-46c2-d7d4-959fc2c3e571, version 11, effective June 1, 2026. NDC 55111-762, one of 8 listings for this product.
Valganciclovir Hydrochloride, powder, for solution
Indications and Usage, quoted from the label by Ajanta Pharma USA Inc. (ANDA212890). Cross-references to other label sections are left out.
Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV Disease: Valganciclovir tablets, USP are 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-]).
Pediatric Patients
Prevention of CMV Disease: Valganciclovir for oral solution is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Source: DailyMed label, set id 178a014b-92c7-44a7-abb8-95d89a2feb8f, version 9, effective November 30, 2025. NDC 27241-159, one of 7 listings for this product.
Questions
What is valganciclovir used for?
The FDA label for valganciclovir (tablet, film coated) lists 2 uses: Adult Patients; Pediatric Patients.
What drug class is valganciclovir?
FDA lists valganciclovir in the Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor and Nucleoside Analog Antiviral established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Valganciclovir
- Is Valganciclovir a controlled substance?Federal schedule
- Generic for ValcyteFDA Orange Book
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitors listFDA drug class
- Nucleoside Analog Antivirals listFDA drug class
- NDC 61269-480Valganciclovir NDC record
- NDC 61269-485Valganciclovir NDC record
- NDC 0591-2579Valganciclovir NDC record