Medicine
Cefprozil 125 mg/5 mL powder for oral suspension
Cefprozil 125 mg/5 mL powder for oral suspension is a generic prescription medicine for oral 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store constituted suspension in refrigerator. Store dry powder at 20° to 25°C…
Key facts
- Active ingredient (INN)
- Cefprozil
- Brand
- Sold under the generic name
- Strength
- 125 mg/5 mL
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 100 mL, 50 mL, 75 mL and 5 more
- Manufacturers
- Aurobindo PharmaIndiaLupinIndiaRising Pharma HoldingsNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Store constituted suspension in refrigerator. Store dry powder at 20° to 25°C (68° to 77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 2005
- Identifiers
- RxCUI 309080, 309081DailyMed set ID 3ec55c0a-1456-412e-972f-352b3135c8f2, 97675251-70b8-43bc-93ea-f9ef6bb8cb68, 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 +1NDC 68180-401, 65862-099, 16714-396 +1Application ANDA065261, ANDA065381
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 |
|---|---|---|---|
| 100 mL in 1 bottle | 65862-099-01 | Aurobindo PharmaIndia | 30 January 2007 |
| 50 mL in 1 bottle | 65862-099-50 | Aurobindo PharmaIndia | 30 January 2007 |
| 75 mL in 1 bottle | 65862-099-75 | Aurobindo PharmaIndia | 30 January 2007 |
| 100 mL in 1 bottle | 68180-401-03 | LupinIndia | 1 December 2005 |
| 100 mL in 1 bottle | 57237-034-01 | Rising Pharma Holdings | 30 January 2007 |
| 50 mL in 1 bottle | 57237-034-50 | Rising Pharma Holdings | 30 January 2007 |
| 75 mL in 1 bottle | 57237-034-75 | Rising Pharma Holdings | 30 January 2007 |
| 100 mL in 1 bottle | 16714-396-03 | NorthStar Rx | 30 January 2007 |
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 23 December 1991 | 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 Cefprozil
Clinical summary
Cefprozil is a cephalosporin antibacterial indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. MedsAcross supplies Cefprozil 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 CefprozilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cefprozil prescribing information (NorthStar Rx) · U.S. National Library of Medicine, DailyMed
Need Cefprozil 125 mg/5 mL powder for oral suspension 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.