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GANCICLOVIR 2 mg/mL Injection, Solution, 250 mL — NDC 51754-2500-1 (Billing 51754-2500-01)

by EXELA PHARMA SCIENCES, LLC · 250 mL in 1 BAG

This is a package of 250 mL of GANCICLOVIR 2 mg/mL Injection, Solution from EXELA PHARMA SCIENCES, LLC, no longer marketed, no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 51754-2500-01
🏷️ FDA NDC (as labeled) 51754-2500-1 billing pads the package segment with a zero
This package
Contains250 mL Pack sizes2 compare ↓
Main listing for product 51754-2500 · Also comes in: 250 mL 51754-2500-3
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 51754-2500-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51754 labeler · 2500 product · 1 package
Billing quantity
250 mL per package
Barcode (UPC-A, from the NDC)
3 5175425001 3
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51754-2500-1
Product NDC 51754-2500
11-digit billing NDC 51754250001
NCPDP billing unit ML — per mL (volume)
Application # NDA209347
SPL Set ID 26361de8-39b5-4266-90f6-2b307940135d
Chemical class Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance GANCICLOVIR

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 077168
GCN 43096
HICL code 009644
Ingredient (HICL) Ganciclovir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5A
Therapeutic class — specific (HIC3) Antivirals, General
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name GANCICLOVIR 500 MG/250 ML BAG
FDB brand name Ganciclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077168
  • GCN: 43096
  • HICL (First Databank): 009644
  • AHFS class code: 08:18.32.00
Why two NDCs? The FDA registers this code as 51754-2500-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51754-2500-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name GANCICLOVIR 500 MG/250 ML BAG Ingredient Ganciclovir
📖 What it is MedlinePlus · NLM

Ganciclovir injection is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in certain people whose immune system is not working normally. It is also used to prevent CMV disease in certain transplant recipients. Ganciclovir injection is in a class of medications called antivirals. It works by stopping the spread of CMV in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ganciclovir is an antiviral that stops certain viruses from copying themselves. The injection form is used mainly to treat or prevent CMV (cytomegalovirus) infections — a serious v...
  • Why has my doctor prescribed ganciclovir — what exactly does it do?
  • The most important ones to watch for with the injection form are signs of low blood counts — things like unusual bruising, bleeding gums, persistent fever, or feeling unusually wea...
  • What side effects should I actually watch out for?
📖 Read our full Ganciclovir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 250 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51754-2500-01 You're viewing this Main listing 250 mL in 1 BAG 2017-02-28 — Discontinued by firm
51754-2500-03 51754-2500-3 10 BAG in 1 POUCH / 250 mL in 1 BAG 2017-02-28 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package contains 250 mL — 250 ml in 1 bag.
What NDC number is used to bill for this package of GANCICLOVIR 2 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ganciclovir 2 mg/mLthis 51754-2500-01 EXELA 250 ml — — Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
First FDA approval
Feb 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 17, 2017 RLD RS ⏳ ~7.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9486530 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9486530 ↗ Drug product — Sep 2, 2034
Common questions
Is there a generic version of GANCICLOVIR 500 MG/250 ML BAG?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for GANCICLOVIR 500 MG/250 ML BAG. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEXELA PHARMA SCIENCES, LLC
Application holderEXELA PHARMA SCIENCES LLC
FDA applicationNDA209347 (NDA)
Labeler code51754
Product typeHuman Prescription Drug
Portfolio24 products on file

More NDCs from EXELA PHARMA SCIENCES, LLC labeler code 51754

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧪 Nonclinical Toxicology 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 214 words ▾

WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, and CARCINOGENICITY Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir [see Warnings and Precautions ( 5.1 )]. Impairment of Fertility: Based on animal data, GANCICLOVIR INJECTION may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )]. Fetal Toxicity: Based on animal data, GANCICLOVIR INJECTION has the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )].

Mutagenesis and Carcinogenesis: Based on animal data, GANCICLOVIR INJECTION has the potential to cause cancer in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATALOGIC TOXICITY, IMPAIRMENT OF FERTILITY, TERATOGENICITY, and CARCINOGENICITY See full prescribing information for complete boxed warning. Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir.

( 5.1 ) Impairment of Fertility: Based on animal data, GANCICLOVIR INJECTION may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. ( 5.2 ) Fetal Toxicity: Based on animal data, GANCICLOVIR INJECTION has the potential to cause birth defects in humans. ( 5.3 ) Mutagenesis and Carcinogenesis: Based on animal data, GANCICLOVIR INJECTION has the potential to cause cancer in humans.

( 5.4 )

🎯 Indications and Usage 120 words ▾

1 INDICATIONS AND USAGE GANCICLOVIR INJECTION is a nucleoside analogue CMV DNA polymerase inhibitor indicated for the: Treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 ) Prevention of CMV disease in adult transplant recipients at risk for CMV disease. ( 1.2 )

1.1Treatment of CMV Retinitis GANCICLOVIR INJECTION is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14 )] .

1.2Prevention of CMV Disease in Transplant Recipients GANCICLOVIR INJECTION is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies ( 14 ) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage in Adult Patients with Normal Renal Function ( 2.3 , 2.4 ) Treatment of CMV retinitis ( 2.3 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients ( 2.4 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days.

Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation. Adult patients with renal impairment: Adjust dosage based on creatinine clearance. ( 2.5 )

2.1Important Dosing and Administration Information Do not administer GANCICLOVIR INJECTION by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels. The recommended dosage and infusion rate for GANCICLOVIR INJECTION should not be exceeded. Administration of GANCICLOVIR INJECTION should be accompanied by adequate hydration.

GANCICLOVIR INJECTION should only be infused into veins with adequate blood flow to permit rapid dilution and distribution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2Testing Before and During Treatment Females of reproductive potential should undergo pregnancy testing before initiation of GANCICLOVIR INJECTION [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 , 8.3 )]. Complete blood counts with differential and platelet counts should be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in cytopenias, or in whom absolute neutrophil counts are less than 1000 cells/μL at the beginning of treatment [see Warnings and Precautions ( 5.1 )] .

All patients should be monitored for renal function before and during treatment with GANCICLOVIR INJECTION and dosage should be adjusted as needed [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.2 )]. Patients with CMV retinitis should have frequent ophthalmological examinations during treatment with GANCICLOVIR INJECTION to monitor disease status and for other retinal abnormalities [see Adverse Reactions ( 6.1 )].

2.3Recommended Dosage for Treatment of CMV Retinitis in Adult Patients with Normal Renal Function Induction Dosage: The recommended initial dosage of GANCICLOVIR INJECTION for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance Dosage: Following induction treatment, the recommended maintenance dosage of GANCICLOVIR INJECTION is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week.

2.4Recommended Dosage for Prevention of CMV Disease in Adult Transplant Recipients with Normal Renal Function Induction Dosage : The recommended initial dosage of GANCICLOVIR INJECTION for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance Dosage : Following induction, the recommended maintenance dosage of GANCICLOVIR INJECTIONS is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation.

2.5Recommended Dosage in Adult Patients with Renal Impairment For patients with renal impairment, refer to Table 1 for recommended doses of GANCICLOVIR INJECTION for induction and maintenance dosage for treatment of CMV retinitis and prevention of CMV disease in transplant patients. Monitor serum creatinine or creatinine c… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 500 mg of ganciclovir in 250 mL (2 mg per mL) sterile, unpreserved, colorless solution in a single-dose bag for intravenous use. Injection: 500 mg ganciclovir in 250 mL (2 mg per mL) solution in a single-dose bag for intravenous use. ( 3 )

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS GANCICLOVIR INJECTION is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. Hypersensitivity to ganciclovir, valganciclovir or acyclovir. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hematologic toxicity: Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been reported with use of ganciclovir. Avoid the use of GANCICLOVIR INJECTION if absolute neutrophil count is less than 500 cells/µL, hemoglobin is less than 8 g/dL, or platelet count is less than 25,000 cells/µL. Use with caution in patients with pre-existing cytopenias or in patients receiving myelosuppressive drugs or irradiation.

Monitor with frequent complete blood and platelet counts. ( 5.1 ) Impairment of renal function: Increased serum creatinine levels have been observed with the use of ganciclovir, particularly in elderly patients and transplant patients receiving concomitant nephrotoxic drugs. Monitor renal function during therapy with GANCICLOVIR INJECTION, particularly in elderly patients and in patients taking other nephrotoxic drugs, and reduce dosage in patients with renal impairment.

( 5.2 ) Impairment of fertility: Based on animal studies, GANCICLOVIR INJECTION may cause temporary or permanent female and male infertility. ( 5.3 ) Fetal toxicity: Based on findings in animal studies, GANCICLOVIR INJECTION may cause fetal toxicity. Females of reproductive potential should use effective contraception during treatment and for at least 30 days following treatment with GANCICLOVIR INJECTION.

Males should practice barrier contraception during treatment and for at least 90 days following treatment with GANCICLOVIR INJECTION. ( 5.4 ) Mutagenicity and carcinogenicity: Based on animal studies, GANCICLOVIR INJECTION is potentially mutagenic and carcinogenic. ( 5.5 )

5.1Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia, and pancytopenia have been observed in patients treated with ganciclovir. The frequency and severity of these events vary widely in different patient populations [see Adverse Reactions ( 6.1 )]. GANCICLOVIR INJECTION is not recommended if the absolute neutrophil count is less than 500 cells/μL, hemoglobin is less than 8 g/dL, or the platelet count is less than 25,000 cells/μL.

GANCICLOVIR INJECTION should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Neutropenia usually occurs during the first or second week of treatment but may occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug.

Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving ganciclovir for treatment of CMV retinitis. Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving GANCICLOVIR INJECTION, complete blood counts with differential and platelet counts should be performed frequently, especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment [see Dosage and Administration ( 2.2 )] .

5.2Impairment of Renal Function Increased serum creatinine levels have been reported in elderly patients and in transplant patients receiving concomitant nephrotoxic medications (i.e., cyclosporine and amphotericin B). Monitoring renal function during therapy with GANCICLOVIR INJECTION is essential, especially for elderly patients and those patients receiving concomitant agents that may cause nephrotoxicity [see Dosage and Administration ( 2.5 ), Use in Specific Populations ( 8.5 )] .

5.3Impairment of Fertility Based on animal data, GANCICLOVIR INJECTION at the recommended human dose (RHD) may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females. Advise patients that fertility may be impaired with use of GANCICLOVIR INJECTION [see Use in Specific Population ( 8.1 ), Nonclinical Toxicology ( 13.1 )] .

5.4Fetal Toxicity GANCICLOVIR INJECTION may cause fetal toxicity whe… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions ( 5.1 )] Impairment of Renal Function [see Warnings and Precautions ( 5.2 )] Impairment of Fertility [see Warnings and Precautions ( 5.3 )] Fetal Toxicity [see Warnings and Precautions ( 5.4 )] Mutagenesis and Carcinogenesis [see Warnings and Precautions ( 5.5 )] Most common adverse reactions and laboratory abnormalities reported in at least 20% of patients were fever, diarrhea, leukopenia, anemia, catheter-related events (including catheter infection and catheter sepsis), and elevated creatinine levels.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Patients with CMV Retinitis Three controlled, randomized, phase 3 trials comparing intravenous ganciclovir and ganciclovir capsules for maintenance treatment of CMV retinitis have been completed. During these trials, 9% of subjects were prematurely discontinued because of adverse reactions.

Selected adverse reactions and laboratory abnormalities reported during the conduct of these controlled trials are summarized in Table 2 and Table 3, respectively [see Clinical Studies ( 14 )] . Table 2. Pooled Selected Adverse Events Reported in ≥ 5% of Subjects Comparing Intravenous Ganciclovir to Ganciclovir Capsules for Maintenance Treatment of CMV Retinitis Adverse Event Maintenance Treatment Studies Intravenous Ganciclovir (n=179) Ganciclovir Capsules (n=326) Fever 48% 38% Diarrhea 44% 41% Leukopenia 41% 29% Anemia 25% 19% Total catheter events: 22% 6% Catheter infection 9% 4% Catheter sepsis 8% 1% Other catheter related events 5% 1% Sepsis 15% 4% Anorexia 14% 15% Vomiting 13% 13% Infection 13% 9% Sweating 12% 11% Chills 10% 7% Neuropathy 9% 8% Thrombocytopenia 6% 6% Pruritus 5% 6% Retinal Detachment Retinal detachment has been observed in subjects with CMV retinitis both before and after initiation of therapy with ganciclovir.

Its relationship to therapy with ganciclovir is unknown. Retinal detachment occurred in 11% of patients treated with intravenous ganciclovir and in 8% of patients treated with ganciclovir capsules. Table 3.

Selected Laboratory Abnormalities in Trials for Treatment of CMV Retinitis Laboratory Abnormalities CMV Retinitis Treatment* Intravenous Ganciclovir† 5mg/kg/day (N=175) % Ganciclovir Capsules‡ 3000mg/day (N=320) % Neutropenia with Absolute Neutrophil Count (ANC) per µL: <500 25% 18% 500 - <749 14% 17% 750 - <1000 16% 19% Anemia with Hemoglobin (g/dL): <6.5 5% 2% 6.5 - <8.0 16% 10% 8.0 - <9.5 26% 25% Serum Creatinine (mg/dL): ≥2.5 2% 1% ≥1.5 - <2.5 14% 12% * Pooled data from treatment studies ICM 1653, ICM 1774, and AVI 034 † Mean time on therapy = 103 days, including allowed re-induction treatment periods ‡ Mean time on therapy = 91 days, including allowed re-induction treatment periods Adverse Reactions in Transplant Recipients There have been three controlled clinical trials of intravenous ganciclovir for the prevention of CMV disease in transplant recipients.

Selected laboratory abnormalities are summarized in Tables 4 and 5 below. Table 4 shows the frequency of neutropenia and thrombocytopenia and Table 5 shows the frequency of elevated serum creatinine values observed in these trials [see Clinical Studies ( 14 )]. Table 4.

Laboratory Abnormalities in Controlled Trials – Transplant Recipients who Received Intravenous Ganciclovir or Placebo Laboratory Abnormalities Heart Allograft* Bone Marrow Allograft† Intravenous Ganciclovir (N=76) Placebo (n=73) Intravenous Ganciclovir (n=57) Control (n=55) Ne… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 [see Clinical Pharmacology ( 12.3 )] . Table 6. Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Didanosine ↑ Didanosine Patients should be closely monitored for didanosine toxicity.

Zidovudine ↓ Ganciclovir ↑ Zidovudine Dose reduction or interruption may be needed because both zidovudine and ganciclovir have the potential to cause neutropenia and anemia. Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels. Probenecid ↑ Ganciclovir GANCICLOVIR INJECTION dose may need to be reduced.

Monitor for evidence of ganciclovir toxicity. Imipenem-cilastatin Unknown Coadministration with imipenem-cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. Cyclosporine or amphotericin B Unknown Monitor renal function when GANCICLOVIR INJECTION is co-administered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions ( 5.2 )].

Dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues Unknown Co-administration with GANCICLOVIR INJECTION should be considered only if the potential benefits are judged to outweigh the risks because of potential additive toxicity. Didanosine: Patients should be closely monitored for didanosine toxicity. ( 7 ) Zidovudine: Potential to cause neutropenia and anemia.

Monitor with frequent tests of white blood cell counts with differential and hemoglobin levels. ( 7 ) Probenecid: Ganciclovir dose may need to be reduced. Monitor for evidence of ganciclovir toxicity.

( 7 ) Imipenem-cilastatin: Generalized seizures have been reported in patients with concomitant use of ganciclovir and imipenem-cilastatin. ( 7 ) Cyclosporine or amphotericin B: Monitor renal function. ( 5.2 , 7 ) Drugs such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulfamethoxazole combinations or other nucleoside analogues should be considered for concomitant use with ganciclovir only if the potential benefits are judged to outweigh the risks.

( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended . ( 8.2 )

8.1Pregnancy Risk Summary Inanimal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (RHD) [see Data] . Although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and on at least one case report in a pregnant woman, no adequate human data are available to establish whether GANCICLOVIR INJECTION poses a risk to pregnancy outcomes.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2-4% and 15−20%, respectively. Clinical considerations Disease-associated maternal and/or fetal risk Most maternal CMV infections are subclinical or they may be associated with a mononucleosis-like syndrome.

However, in immunocompromised patients, CMV infections are often symptomatic and are associated with significant morbidity and mortality. The transmission of CMV to the fetus is a result of maternal viremia and transplacental infection. CMV infection can also occur perinatally from mother to infant by exposure to CMV in cervicovaginal secretions.

Approximately 10% of infected newborns are symptomatic at birth. Mortality in symptomatic infants is about 10%, and approximately 50 to 90% of survivors experience significant problems, including sensorineural hearing loss, mental retardation, and other neurologic deficits. The risk and severity of congenital CMV infection appear to be higher in infants born to mothers with primary CMV infection than in those born to mothers with reactivation of CMV infection.

Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice (108 mg/kg/day) and rabbits (60 mg/kg/day), and also to female mice (90 mg/kg) prior to mating, during gestation, and during lactation. Fetal resorptions were present in at least 85% of rabbits and mice. Additional effects observed in rabbits included fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity.

Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. In pre/postnatal development studies in mice, there were maternal/fetal toxicity and embryolethality which included fetal effects of hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach. The systemic exposure (AUC) of ganciclovir during these studies was approximately 2-times (pregnant mice and rabbits) and 1.7-times (pre/postnatal mice) the exposure in humans at the RHD [see Nonclinical Toxicology ( 13.1 )] .

8.2Lactation Risk Summary No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production. When ganciclovir was administered to lactating rats, ganciclovir was present in milk [see Data]. Advise nursing mothers that breastfeeding is not recommended during treatment with GANCICLOVIR INJECTION because of the potential for serious adverse reactions in nursing infants.

Furthermore, the Centers for Disease Control and Prevention recommends that HIV-infected mothers not breastfeed their infants to avoid potential postnatal transmission of HIV [see Warnings and Precautions ( 5.1 , 5.3 , 5.5 ), Nonclinical Toxicology ( 13.1 )]. Data Animal Data Ganciclovir administered intravenously (at 0.13 mg/h) to lactating rats (on lactation day 15) resulted in passive transfer into milk. The milk-to-serum ratio for ganciclovir at steady state was 1.6 ± 0.33.

8.3Females and Males of Reproductive Potential Pregnancy Testing Females of reproducti… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 67 words ▾

10 OVERDOSAGE Adverse reactions reported with overdosage of intravenous ganciclovir included irreversible pancytopenia, acute renal failure requiring hemodialysis, neutropenia, thrombocytopenia, hepatitis, and seizures. Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations. Adequate hydration should be maintained.

The use of hematopoietic growth factors should be considered in patients with cytopenias [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ganciclovir is an antiviral drug with activity against cytomegalovirus (CMV) [see Microbiology ( 12.4 )].

12.3Pharmacokinetics Absorption: At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ±3.2 (n=16) and 26.8 ± 6.1 g·hr/mL (n=16) and C max ranged between 8.27 ± 1.02 (n=16) and 9.0 ± 1.4 g/mL (n=16). Distribution: The steady-state volume of distribution of ganciclovir after intravenous administration was 0.74 ±

0.15L/kg (n=98). Cerebrospinal fluid concentrations obtained 0.25 to 5.67 hours post-dose in 3 patients who received 2.5 mg/kg ganciclovir intravenously every 8 hours or every 12 hours ranged from 0.31 to 0.68 g/mL representing 24% to 70% of the respective plasma concentrations. Binding to plasma proteins was 1% to 2% over ganciclovir concentrations of 0.5 and 51 g/mL.

Elimination: Renal excretion of unchanged drug by glomerular filtration and active tubular secretion is the major route of elimination of ganciclovir. In patients with normal renal function, 91.3 ± 5.0% (n=4) of intravenously administered ganciclovir was recovered unchanged in the urine. Systemic clearance of intravenously administered ganciclovir was 3.52 ± 0.80 mL/min/kg (n=98) while renal clearance was 3.20 ± 0.80 mL/min/kg (n=47), accounting for 91 ± 11% of the systemic clearance (n=47).

Following intravenous administration, ganciclovir half-life was 3.5 ± 0.9 hours (n=98) with linear pharmacokinetics over the dose range of 1.6 to 5.0 mg/kg. Specific Populations Patients with Renal Impairment The pharmacokinetics of ganciclovir following intravenous administration of ganciclovir were evaluated in 10 immunocompromised patients with renal impairment who received doses ranging from 1.25 to 5.0 mg/kg (Table 7). Hemodialysis reduces plasma concentrations of ganciclovir by about 50% after intravenous administration.

Table 7. Pharmacokinetics of Ganciclovir in Patients with Renal Impairment Estimated Creatinine Clearance (mL/min) n Dose Clearance (mL/min) Mean ± SD Half-life (hours) Mean ± SD 50-79 4 3.2-5 mg/kg 128 ± 63 4.6 ± 1.4 25-49 3 3-5 mg/kg 57 ± 8 4.4 ± 0.4 <25 3 1.25-5 mg/kg 30 ± 13 10.7 ±

5.7Race (Ethnicity) and Gender The effects of race/ethnicity and gender were studied in subjects receiving a dose regimen of 1000 mg every 8 hours. Although the numbers of Blacks (16%) and Hispanics (20%) were small, there appeared to be a trend towards a lower steady-state C max and AUC 0-8 in these subpopulations as compared to Caucasians. No definitive conclusions regarding gender differences could be made because of the small number of females (12%); however, no differences between males and females were observed.

Drug Interactions Didanosine When the standard intravenous ganciclovir induction dose (5 mg/kg infused over 1 hour every 12 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, the steady-state didanosine AUC 0-12 increased 70 ± 40% (range: 3% to 121%, n=11) and C max increased 49 ± 48% (range: -28% to 125%). In a separate study, when the standard intravenous ganciclovir maintenance dose (5 mg/kg infused over 1 hour every 24 hours) was coadministered with didanosine at a dose of 200 mg orally every 12 hours, didanosine AUC 0-12 increased 50 ± 26% (range: 22% to 110%, n=11) and C max increased 36 ± 36% (range: -27% to 94%) over the first didanosine dosing interval.

Ganciclovir pharmacokinetics were not affected by didanosine. In both studies, there was no significant change in the renal clearance of either drug. Zidovudine At an oral dose of 1000 mg of ganciclovir every 8 hours, mean steady-state ganciclovir AUC 0-8 decreased 17 ± 25% (range: -52% to 23%) in the presence of zidovudine, 100 mg every 4 hours (n=12).

Steady-state zidovudine AUC 0-4 increased 19 ± 27% (range: -11% to 74%) in the presence of ganciclovir. No drug-drug interaction studies have been conducted with intravenous ganciclovir and zidovudine. Probenec… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING GANCICLOVIR INJECTION is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 500 mg ganciclovir in 250 mL of solution (2 mg/mL) sealed with a Twist Off port from Technoflex, and oversealed in an aluminum pouch (NDC 51754-2500-1), in cases of 10 (NDC 51754-2500-3). Follow guidelines for handling and disposal for cytotoxic drugs. 1 The premix flexible plastic container bag contains no preservative; any unused portion should be discarded [see Dosage and Administration ( 2.6 )] .

Gently shaking should redissolve any crystals that may have formed during transportation and/or storage at temperatures lower than recommended. The solution must be clear at the time of use. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 173 words ▾

11 DESCRIPTION GANCICLOVIR INJECTION, 500 mg is a sterile, unpreserved solution for intravenous administration. The appearance of the solution is clear and colorless. Each mL contains 2.0 mg of ganciclovir, 8.0 mg of sodium chloride in water for injection, and may contain sodium hydroxide, and/or hydrochloric acid, as required to adjust the pH to 7.5.

Ganciclovir, an antiviral agent, is a synthetic guanine derivative, 9-[[2-hydroxy-1-(hydroxymethyl)- ethoxy]methyl]guanine. Ganciclovir is a white to off-white crystalline powder with a molecular formula of C 9 H 13 N 5 0 4 and a molecular weight of 255.23. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022.

The pK a s for ganciclovir are 2.2 and 9.4. The chemical structure of ganciclovir is: The plastic container is fabricated from a multilayer film designed for medical use. The solution is in contact with the inner polypropylene layer of the container.

No components of the plastic container material were found to migrate into the solution. Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Hematologic Toxicity Inform patients of the potential for hematologic toxicity associated with the use of GANCICLOVIR INJECTION including granulocytopenia (neutropenia), anemia and thrombocytopenia. Inform patients that their blood counts will be closely monitored while on therapy [see Warnings and Precautions (5.1)] . Impairment of Renal Function Inform patients that ganciclovir has been associated with decreased renal function and that serum creatinine or creatinine clearance will be monitored carefully to allow for dosage adjustment in patients with renal impairment [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].

Impairment of Fertility Inform patients that ganciclovir has caused decreased fertility in animals and may cause temporary or permanent infertility in humans [see Warnings and Precautions (5.3), Use in Specific Populations (8.3)]. Pregnancy and Contraception Inform women of childbearing potential that ganciclovir causes birth defects in animals. Advise female patients to use effective contraception during treatment and for at least 30 days following treatment with GANCICLOVIR INJECTION.

Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with GANCICLOVIR INJECTION [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)] . Carcinogenicity Inform patients that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen [see Warnings and Precautions (5.5)] .

Drug Interactions Inform patients that GANCICLOVIR INJECTION may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions (7)]. Ophthalmological Examination in Patients with CMV Retinitis Advise patients with CMV retinitis to have frequent ophthalmological examinations while being treated with GANCICLOVIR INJECTION to monitor disease status and for other retinal abnormalities.

More frequent ophthalmological follow-up may be needed in some cases [see Dosage and Administration (2.2), Adverse Reactions (6.1)]. Lactation Advise nursing mothers that breastfeeding is not recommended during treatment with GANCICLOVIR INJECTION because of the potential for serious adverse events in nursing infants and because HIV can be passed to the baby in breast milk [see Use in Specific Populations (8.2)] .

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, Mutagenesis Ganciclovir was carcinogenic in mice at the same mean drug exposure in humans as at the RHD (5 mg/kg). At the dose of 1000 mg/kg/day (1.4 times the exposure at the RHD) there was a significant increase in the incidence of tumors of the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland and vagina) and liver in females. At the dose of 20 mg/kg/day (0.1 times the exposure at the RHD), a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, forestomach in males and females, and liver in females.

No carcinogenic effect was observed in mice administered ganciclovir at 1 mg/kg/day (exposure estimated as 0.01 times the RHD). Except for histiocytic sarcoma of the liver, ganciclovir-induced tumors were generally of epithelial or vascular origin. Although the preputial and clitoral glands, forestomach and harderian glands of mice do not have human counterparts, ganciclovir should be considered a potential carcinogen in humans.

Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes in vitro at concentrations of 50 to 500 and 250 to 2000 μg/mL, respectively. In the mouse micronucleus assay, ganciclovir was clastogenic at doses of 150 and 500 mg/kg (2.8 to 10 times the exposure at the RHD) but not at doses of 50 mg/kg (exposure approximately comparable to the RHD). Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5000 μg/mL.

Impairment of Fertility Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following doses of 90 mg/kg/day (exposures approximately 1.7 times the RHD). Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration of doses ranging from 0.2 to 10 mg/kg. Systemic drug exposure (AUC) at the lowest dose showing toxicity in each species ranged from 0.03 to 0.1 times the exposure at the RHD.

📚 References 9 words ▾

15 REFERENCES “OSHA Hazardous Drugs.” OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html .

📄 Package Label / Principal Display Panel 40 words ▾

Principal Display Panel NDC 51754-2500-1 250 mL GANCICLOVIR INJECTION 500 mg per 250 mL (2 mg per mL) 0.8% sodium chloride solution Single-dose for intravenous use only Discard unused portion of drug Bag Overwrap Label Container Label Bag Label Overwrap

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zirgan (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zirgan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.02M
Claims incl. refills
4.1K
Beneficiaries
3.1K
Spend / beneficiary
$654.48
Spend / claim
$488.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ganciclovir — the ingredient across all brands.

Top reported reactions

Cytomegalovirus Infection1,266
Drug Resistance731
Pyrexia619
Neutropenia598
Pancytopenia554
Diarrhoea470
Cytomegalovirus Viraemia438

Age at onset

Neonate32
Infant135
Child168
Adolescent75
Adult946
Elderly374

Reporter sex

0 reports

Serious outcomes

Life-threatening1,179
Disabling213
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,042 332
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 pouch (51754-2500-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
EXELA PHARMA SCIENCES, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51754-2004-01 · Exela 51754-4200-04 · Exela →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.