Medicine
Ganciclovir 500 mg/10 mL powder for injection
Ganciclovir 500 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not refrigerate or freeze. Do not freeze. Store vials at 20° to 25°C (68°…
Key facts
- Active ingredient (INN)
- Ganciclovir
- Brand
- Sold under the generic name
- Strength
- 500 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 25 vials, 10 vials and 3 more
- Manufacturers
- Fresenius KabiSlate Run PharmaceuticalsHikma PharmaceuticalsPar Health
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Do not freeze. Store vials at 20° to 25°C (68° to 77°F). Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AB06 Ganciclovir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 June 2010
- Identifiers
- RxCUI 310442DailyMed set ID 35addab5-09db-4f8a-9c69-6fbce33ecc37, 87afd103-6e64-444f-971d-0e732e9ae995, b47f5d1c-36b8-49b6-a410-3b3f4661dde7 +3NDC 63323-315, 42023-173, 0143-9299 +2Application ANDA090658, ANDA204950, ANDA076222 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-315-10 | Fresenius Kabi | 28 June 2010 |
| 25 vial in 1 tray / 10 mL in 1 vial | 63323-315-94 | Fresenius Kabi | 28 June 2010 |
| 25 vial in 1 carton / 10 mL in 1 vial | 70436-089-55 | Slate Run Pharmaceuticals | 1 January 2019 |
| 25 vial in 1 carton / 10 mL in 1 vial | 70436-231-55 | Slate Run Pharmaceuticals | 1 September 2024 |
| 10 vial in 1 box / 10 mL in 1 vial | 0143-9299-10 | Hikma Pharmaceuticals | 17 June 2021 |
| 25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 42023-173-25 | Par Health | 6 December 2016 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Ganciclovir
Clinical summary
Ganciclovir is a cytomegalovirus nucleoside analog DNA polymerase inhibitor indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. MedsAcross supplies Ganciclovir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about GanciclovirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZIRGAN prescribing information (Bausch & Lomb) · U.S. National Library of Medicine, DailyMed
Need Ganciclovir 500 mg/10 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.