FDA — authorised 10 May 1974
- Application: NDA017546
- Marketing authorisation holder: ROCHE
- Local brand name: NIPRIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 SODIUM NITROPRUSSIDE in United States
FDA authorised SODIUM NITROPRUSSIDE on 10 May 1974 · 543 US adverse-event reports
Marketing authorisations
FDA — authorised 28 July 1982
- Application: NDA018581
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 1992
- Application: ANDA073465
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2016
- Application: ANDA207426
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 2017
- Application: NDA209387
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: NIPRIDE RTU IN SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2017
- Application: ANDA208635
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 May 2017
- Application: ANDA207499
- Marketing authorisation holder: NEXUS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 2017
- Application: ANDA209493
- Marketing authorisation holder: AMNEAL
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA209352
- Marketing authorisation holder: MICRO LABS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2017
- Application: ANDA209832
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA210763
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 June 2018
- Application: ANDA209834
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA210855
- Marketing authorisation holder: CIPLA
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 2018
- Application: ANDA210882
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 2018
- Application: ANDA210467
- Marketing authorisation holder: SUN PHARM
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA210114
- Marketing authorisation holder: DR REDDYS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA211016
- Marketing authorisation holder: CAPLIN
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 August 2020
- Application: ANDA214199
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 2021
- Application: ANDA214971
- Marketing authorisation holder: BE PHARMS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 August 2022
- Application: ANDA215846
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 November 2022
- Application: ANDA208923
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070031
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: SODIUM NITROPRUSSIDE
- 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: 543
Most-reported reactions
- Renal Failure — 74 reports (13.63%)
- Pain — 62 reports (11.42%)
- Injury — 59 reports (10.87%)
- Anxiety — 58 reports (10.68%)
- Unevaluable Event — 55 reports (10.13%)
- Drug Ineffective — 53 reports (9.76%)
- Fear — 53 reports (9.76%)
- Renal Injury — 44 reports (8.1%)
- Emotional Distress — 43 reports (7.92%)
- Toxicity To Various Agents — 42 reports (7.73%)
SODIUM NITROPRUSSIDE 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 SODIUM NITROPRUSSIDE approved in United States?
Yes. FDA authorised it on 10 May 1974; FDA authorised it on 28 July 1982; FDA authorised it on 30 March 1992.
Who is the marketing authorisation holder for SODIUM NITROPRUSSIDE in United States?
ROCHE holds the US marketing authorisation.