FDA — authorised 8 January 1987
- Application: ANDA062757
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: MEFOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CEFOXITIN SODIUM in United States
FDA authorised CEFOXITIN SODIUM on 8 January 1987 · 101 US adverse-event reports
Marketing authorisations
FDA — authorised 25 January 1993
- Application: ANDA063182
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: MEFOXIN IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 1997
- Application: NDA050581
- Marketing authorisation holder: MERCK
- Local brand name: MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 November 2015
- Application: ANDA200938
- Marketing authorisation holder: SAMSON MEDCL
- Local brand name: CEFOXITIN IN PLASTIC CONTAINER
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 101
Most-reported reactions
- Off Label Use — 16 reports (15.84%)
- Pneumonia — 11 reports (10.89%)
- Thrombocytopenia — 11 reports (10.89%)
- Drug Hypersensitivity — 10 reports (9.9%)
- Nausea — 10 reports (9.9%)
- Pyrexia — 9 reports (8.91%)
- Rash — 9 reports (8.91%)
- Urinary Tract Infection — 9 reports (8.91%)
- Acute Kidney Injury — 8 reports (7.92%)
- Diarrhoea — 8 reports (7.92%)
CEFOXITIN SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CEFOXITIN SODIUM approved in United States?
Yes. FDA authorised it on 8 January 1987; FDA authorised it on 25 January 1993; FDA authorised it on 27 February 1997.
Who is the marketing authorisation holder for CEFOXITIN SODIUM in United States?
PHARMOBEDIENT holds the US marketing authorisation.