FDA — authorised 21 December 1984
- Application: NDA050585
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN KIT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CEFTRIAXONE SODIUM in United States
FDA authorised CEFTRIAXONE SODIUM on 21 December 1984 · 3,449 US adverse-event reports
Marketing authorisations
FDA — authorised 11 February 1987
- Application: NDA050624
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 April 2005
- Application: NDA050796
- Marketing authorisation holder: B BRAUN
- Local brand name: CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2005
- Application: ANDA065204
- Marketing authorisation holder: SANDOZ INC
- Status: supplemented
FDA — authorised 9 May 2005
- Application: ANDA065169
- Marketing authorisation holder: SANDOZ
- Status: supplemented
FDA — authorised 17 May 2005
- Application: ANDA065168
- Marketing authorisation holder: SANDOZ
- Status: supplemented
FDA — authorised 23 August 2005
- Application: ANDA065224
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CEFTRIAXONE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2016
- Application: ANDA203702
- Marketing authorisation holder: QILU ANTIBIOTICS
- Status: approved
FDA — authorised 20 January 2017
- Application: ANDA091117
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFTRIAXONE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 October 2017
- Application: ANDA090701
- Marketing authorisation holder: HIKMA
- Local brand name: CEFTRIAXONE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 October 2018
- Application: ANDA209218
- Marketing authorisation holder: QILU ANTIBIOTICS
- Status: supplemented
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: 3,449
Most-reported reactions
- Dyspnoea — 500 reports (14.5%)
- Off Label Use — 407 reports (11.8%)
- Drug Ineffective — 385 reports (11.16%)
- Pyrexia — 343 reports (9.94%)
- Nausea — 329 reports (9.54%)
- Drug Hypersensitivity — 328 reports (9.51%)
- Pneumonia — 319 reports (9.25%)
- Vomiting — 295 reports (8.55%)
- Cough — 275 reports (7.97%)
- Urticaria — 268 reports (7.77%)
CEFTRIAXONE 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 CEFTRIAXONE SODIUM approved in United States?
Yes. FDA authorised it on 21 December 1984; FDA authorised it on 11 February 1987; FDA authorised it on 20 April 2005.
Who is the marketing authorisation holder for CEFTRIAXONE SODIUM in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.