Quick answers
- What is Ganciclovir used for?
- The FDA-approved label (Zirgan, Bausch & Lomb Incorporated, May 18, 2026) says: “ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ZIRGAN is a nucleoside analog antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ganciclovir have a boxed warning?
- The label we quote has no boxed warning, but 7 of 8 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Ganciclovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ganciclovir been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 16, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ganciclovir?
- 7 companies list prescription products of Ganciclovir in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Slate Run Pharmaceuticals, LLC and Pharmascience Inc..
What Ganciclovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ZIRGAN is a nucleoside analog antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older.
— FDA label: Zirgan, Bausch & Lomb Incorporated, effective May 18, 2026. Read the full label on DailyMed →
The FDA has 8 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.
The label quoted above has no boxed warning.
7 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, solution · Gel |
|---|---|
| Route | Intravenous · Ophthalmic |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Zirgan |
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 |
|---|---|---|
| ganciclovir 0.15% gel | Brand: Zirgan | $91.24 per gram |
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.
- Fresenius Kabi USA, LLC2 products
- Slate Run Pharmaceuticals, LLC2 products
- Pharmascience Inc.1 product
- Sagent Pharmaceuticals1 product
- Par Health USA, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Bausch & Lomb Incorporated1 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 |
|---|---|---|---|
| NDA022211 ZIRGAN | Bausch and Lomb | September 15, 2009 | 4, latest January 20, 2026 2026: Labeling · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
Generic approvals (5)
- ANDA076222Hikma · July 16, 2003
- ANDA090658Fresenius Kabi USA · June 21, 2010
- ANDA204950Ph Health · December 6, 2016
- ANDA207645Pharmascience Inc · December 8, 2017
- ANDA204204Hainan Poly · November 8, 2018
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.
-
December 16, 2022 · Class II · Terminated · D-0090-2023
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01 — Hikma Pharmaceuticals USA Inc.
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) | 310442, 388052, 864650, 1999531 |
|---|---|
| SPL set ID of the quoted label | ea25e7ac-7a93-4ec8-975b-2cec197e1c27 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA022211, 5 ANDA |
| Active ingredients (FDA) | GANCICLOVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zirgan, Bausch & Lomb Incorporated, effective May 18, 2026; 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 →