Medicine
Fosfomycin 3 g oral solution
Fosfomycin 3 g oral solution is a generic prescription medicine for oral use, made by 8 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
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Fosfomycin
- Brand
- Sold under the generic name
- Strength
- 3 g
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 packet, 1 dose pack, 1 granule and 6 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaCiplaIndiaAucta PharmaceuticalsA-S Medication SolutionsAmneal Pharmaceuticals NYANI PharmaceuticalsKesin Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XX01 Fosfomycin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 October 2021
- Identifiers
- RxCUI 808917DailyMed set ID aacd04a4-f2d5-45a2-b9e7-0e92244a5880, 4f206750-8126-99a3-e063-6294a90ade4c, 3fa61bd4-fc55-0987-e063-6394a90abce2 +5NDC 60219-3955, 73289-0067, 81033-024 +5Application ANDA216600, ANDA217772, ANDA214554 +3
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 |
|---|---|---|---|
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 67877-749-57 | Ascend LaboratoriesIndia | 22 October 2021 |
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 59651-651-03 | Aurobindo PharmaIndia | 14 November 2025 |
| 1 dose pack in 1 carton / 1 granule, for solution in 1 dose pack | 69097-579-67 | CiplaIndia | 26 January 2022 |
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 60219-3955-1 | Amneal Pharmaceuticals NY | 2 April 2024 |
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 70954-040-10 | ANI Pharmaceuticals | 1 October 2026 |
| 1 granule, for solution in 1 packet | 73289-0067-1 | Aucta Pharmaceuticals | 9 April 2026 |
| 1 dose pack in 1 carton / 1 granule, for solution in 1 dose pack | 73289-0067-2 | Aucta Pharmaceuticals | 9 April 2026 |
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 50090-6130-0 | A-S Medication Solutions | 3 October 2022 |
| 1 packet in 1 carton / 1 granule, for solution in 1 packet | 81033-024-11 | Kesin Pharma | 1 October 2025 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 December 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Fosfomycin
Clinical summary
Fosfomycin is a prescription medicine indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. MedsAcross supplies Fosfomycin 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 FosfomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Contepo prescribing information (Meitheal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fosfomycin 3 g oral solution 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.