FDA — authorised 10 January 1986
- Application: ANDA062590
- Marketing authorisation holder: LILLY
- Local brand name: KEFUROX IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CEFUROXIME SODIUM in United States
FDA authorised CEFUROXIME SODIUM on 10 January 1986 · 1,062 US adverse-event reports
Marketing authorisations
FDA — authorised 10 January 1986
- Application: ANDA062592
- Marketing authorisation holder: LILLY
- Local brand name: KEFUROX
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 January 1986
- Application: ANDA062591
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: KEFUROX
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 28 April 1989
- Application: NDA050643
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: ZINACEF IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1993
- Application: ANDA064036
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 1993
- Application: ANDA064035
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 1997
- Application: ANDA064125
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 1997
- Application: ANDA064124
- Marketing authorisation holder: ACS DOBFAR SPA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 1998
- Application: ANDA064192
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 16 April 1998
- Application: ANDA064191
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 1998
- Application: ANDA065002
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 February 2001
- Application: NDA050780
- Marketing authorisation holder: B BRAUN
- Local brand name: CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 2001
- Application: ANDA065001
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 9 January 2004
- Application: ANDA065048
- Marketing authorisation holder: HIKMA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 January 2004
- Application: ANDA065046
- Marketing authorisation holder: HIKMA
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 October 2008
- Application: ANDA065503
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFUROXIME SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 December 2009
- Application: ANDA065251
- Marketing authorisation holder: SAMSON MEDCL
- Local brand name: CEFUROXIME SODIUM IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- 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: 1,062
Most-reported reactions
- Dyspnoea — 153 reports (14.41%)
- Hypersensitivity — 132 reports (12.43%)
- Off Label Use — 131 reports (12.34%)
- Headache — 107 reports (10.08%)
- Condition Aggravated — 100 reports (9.42%)
- Anxiety — 89 reports (8.38%)
- Angioedema — 88 reports (8.29%)
- Pain In Extremity — 88 reports (8.29%)
- Swelling Face — 88 reports (8.29%)
- Haemoptysis — 86 reports (8.1%)
CEFUROXIME 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 CEFUROXIME SODIUM approved in United States?
Yes. FDA authorised it on 10 January 1986; FDA authorised it on 10 January 1986; FDA authorised it on 10 January 1986.
Who is the marketing authorisation holder for CEFUROXIME SODIUM in United States?
LILLY holds the US marketing authorisation.