Regulatory PathRegulatory requirements compared

Active substance

Sodium nitroprusside

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Sodium Nitroprusside25 mg/mlSolution for injection · Intravenous use1 VialSAR 230.40Generic · PrescriptionHainan Poly Pharm. Co., Ltd.Valid
NIPRIDE DOUBLE 50 MG AMP.50 mgSolution · Parenteral use5 AmpouleSAR 131.05NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
SOD.NITROPRUSSIDE 50MG VIAL50 mgInjection · Parenteral use5 VialSAR 122.30Generic · PrescriptionHOSPIRA AUSTRALIAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HYPERTENSION

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionSAGENT PHARMS INCPrescription8 Dec 2016
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%50MG/100ML (0.5MG/ML); 20MG/100ML (0.2MG/ML)solution · intravenousEXELA PHARMAPrescription8 Mar 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionNEXUSPrescription25 May 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionAMNEALPrescription7 Nov 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionMICRO LABSPrescription8 Dec 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionMYLAN LABS LTDPrescription17 Apr 2018
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionSOMERSET THERAPS LLCPrescription17 Aug 2018
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionDR REDDYSPrescription10 Apr 2019
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionCAPLINPrescription29 Nov 2019
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionHAINAN POLYPrescription25 Aug 2020
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionBE PHARMSPrescription12 Jul 2021
SODIUM NITROPRUSSIDE10MG/50ML (0.2MG/ML); 20MG/100ML (0.2MG/ML); 50MG/100ML (0.5MG/ML)solution · intravenousHAINAN POLYPrescription26 Aug 2022
NIPRIDE50MG/VIALinjectable · injectionROCHEDiscontinued10 May 1974
NITROPRESS50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionABBVIEDiscontinued8 Sep 1981
SODIUM NITROPRUSSIDE50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionBAXTER HLTHCAREDiscontinued28 Jul 1982
NITROPRESS50MG/VIALinjectable · injectionHOSPIRADiscontinued9 Jun 1986
NITROPRESS50MG/VIALinjectable · injectionABBOTTDiscontinued16 Nov 1987
NITROPRESS25MG/MLinjectable · injectionVPNADiscontinued1 Aug 1988
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionTEVA PARENTERALDiscontinued30 Mar 1992
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · intravenousEXELA PHARMADiscontinued8 Mar 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionEPIC PHARMA LLCDiscontinued4 May 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionAMPHASTAR PHARMS INCDiscontinued18 Dec 2017
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionCHARTWELL RXDiscontinued26 Jun 2018
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionCIPLADiscontinued16 Jul 2018
SODIUM NITROPRUSSIDE25MG/MLinjectable · injectionPHARMOBEDIENTDiscontinued10 Aug 2018

5 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SODIUM NITROPRUSSIDE FOR INJECTION0245008925 MG / MLSOLUTION · INTRAVENOUSSTERIMAX INC
SODIUM NITROPRUSSIDE FOR INJECTION0247910925 MG / MLSOLUTION · INTRAVENOUSMARCAN PHARMACEUTICALS INC
SODIUM NITROPRUSSIDE FOR INJECTION0250740425 MG / MLSOLUTION · INTRAVENOUSDR REDDY'S LABORATORIES LTD
SODIUM NITROPRUSSIDE FOR INJECTION0254212925 MG / MLSOLUTION · INTRAVENOUSJAMP PHARMA CORPORATION

WHO WHO Model List of Essential Medicines (2025)

  • 12.3. Antihypertensive medicines · complementary
    Hypertensive crisis
    Parenteral > General injections > IV: 50 mg in ampoule powder for infusion

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.