Quick answers
- What is Valganciclovir used for?
- The FDA-approved label (Valcyte, H2-Pharma, LLC, December 8, 2025) says: “VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Valganciclovir have a boxed warning?
- Yes. The FDA label for Valcyte has a boxed warning (“WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Valganciclovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Valganciclovir been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 4, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Valganciclovir?
- 20 companies list prescription products of Valganciclovir in the FDA NDC Directory, including H2-Pharma, LLC, Strides Pharma Science Limited and Aurobindo Pharma Limited.
What Valganciclovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. …
— FDA label: Valcyte, H2-Pharma, LLC, effective December 8, 2025. Read the full label on DailyMed →
The FDA has 25 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
. Read it on the full label →
25 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Powder, for solution · For solution · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Valcyte |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| valganciclovir 50 mg/mL for solution | Generic | $1.03 per mL |
| valganciclovir 50 mg/mL powder, for solution | Generic | $1.03 per mL |
| valganciclovir hydrochloride 450 mg tablet | Generic | $1.84 per tablet |
| valganciclovir hydrochloride 450 mg tablet, film coated | Generic | $1.84 per tablet |
| valganciclovir hydrochloride 50 mg/mL for solution | Generic | $1.03 per mL |
| valganciclovir hydrochloride 50 mg/mL powder, for solution | Generic | $1.03 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- H2-Pharma, LLC2 products
- Strides Pharma Science Limited2 products
- Aurobindo Pharma Limited2 products
- Camber Pharmaceuticals, Inc.2 products
- Ajanta Pharma USA Inc.2 products
- American Health Packaging2 products
- AvKARE2 products
- NorthStar Rx LLC1 product
- NorthStar RxLLC1 product
- Dr. Reddy's Laboratories Limited1 product
- Major Pharmaceuticals1 product
- Micro Labs Limited1 product
- airis PHARMA PVT LTD1 product
- Novadoz Pharmaceuticals LLC1 product
- Actavis Pharma, Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- AvPAK1 product
- Florida Pharmaceutical Products, LLC1 product
- Somerset Therapeutics, LLC1 product
- Granules Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021304 VALCYTE | Cheplapharm | March 29, 2001 | 11, latest December 23, 2021 2021: Labeling · 2020: Labeling · 2020: Labeling |
| NDA022257 VALCYTE | Cheplapharm | August 28, 2009 | 9, latest December 23, 2021 2021: Labeling · 2020: Labeling · 2020: Manufacturing (CMC) |
Generic approvals (14)
- ANDA200790Strides Pharma Intl · November 4, 2014
- ANDA203511DR Reddys · November 4, 2014
- ANDA205166Hetero Labs Ltd V · March 18, 2016
- ANDA204750Aurobindo Pharma Ltd · March 31, 2016
- ANDA205220Actavis Labs Fl Inc · July 18, 2016
- ANDA206876DR Reddys · December 12, 2017
- ANDA212234Ajanta Pharma Ltd · December 26, 2019
- ANDA212890Ajanta Pharma Ltd · January 13, 2020
- ANDA213306Granules · January 31, 2020
- ANDA210169Msn · February 17, 2022
- ANDA211475Hetero Labs Ltd V · October 4, 2022
- ANDA215124Aurobindo Pharma · November 17, 2022
- ANDA216317Appco · April 11, 2023
- ANDA218838Micro Labs · March 19, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 4, 2019 · Class II · Terminated · D-0518-2020
Presence of foreign substance: Brown/black particles found during stability testing.
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany — Teva Pharmaceuticals USA, Inc.
-
February 13, 2018 · Class II · Terminated · D-0601-2018
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. — Hetero Labs Limited Unit V
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 284587, 313566, 863559, 863562 |
|---|---|
| SPL set ID of the quoted label | 4c517a39-2ded-4c5a-8d56-276853414b31 |
| FDA labels (SPL) | 25 |
| FDA applications | NDA021304, NDA022257, 14 ANDA |
| Active ingredients (FDA) | VALGANCICLOVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Valcyte, H2-Pharma, LLC, effective December 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →