Regulatory PathRegulatory requirements compared

Active substance

Nizatidine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FIXIT 150MG CAPSULE150 mgCapsule, hard · Oral use14 BlisterSAR 26.20Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
FIXIT 150MG CAPSULE150 mgCapsule, hard · Oral use28 BlisterSAR 52.40Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
FIXIT 300MG CAPSULE300 mgCapsule, hard · Oral use14 BlisterSAR 52.40Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
AXID 150MG CAPS150 mgCapsule · Oral use28 BlisterSAR 58.25NCE · PrescriptionEli Lilly and CompanyWithdrawn by MAH · Not Marketed
AXID 300MG CAPS300 mgCapsule · Oral use14 BlisterSAR 58.25NCE · PrescriptionEli Lilly and CompanyWithdrawn by MAH · Not Marketed
FIXIT 75MG CAPSULE75 mgCapsule, hard · Oral use14 BlisterSAR 19.30Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyWithdrawn by MAH · Not Marketed
FIXIT 75MG CAPSULE75 mgCapsule, hard · Oral use28 BlisterSAR 33.40Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD); PEPTIC ULCER

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

ProductStrengthForm · routeApplicantStatusFirst approved
AXID AR75MGtablet · oralHALEON US HOLDINGSOver-the-counter9 May 1996
NIZATIDINE150MG; 300MGcapsule · oralEPIC PHARMA LLCPrescription5 Jul 2002
NIZATIDINE150MG; 300MGcapsule · oralWATSON LABSPrescription9 Jul 2002
NIZATIDINE150MG; 300MGcapsule · oralDR REDDYS LABS LTDPrescription15 Sep 2005
AXID150MG; 300MGcapsule · oralSMITHKLINE BEECHAMDiscontinued12 Apr 1988
NIZATIDINE150MG; 300MGcapsule · oralPHARMOBEDIENTDiscontinued5 Jul 2002
NIZATIDINE150MG; 300MGcapsule · oralANI PHARMSDiscontinued8 Jul 2002
NIZATIDINE150MG; 300MGcapsule · oralMYLAN PHARMS INCDiscontinued9 Jul 2002
NIZATIDINE150MG; 300MGcapsule · oralANI PHARMSDiscontinued12 Sep 2002
NIZATIDINE150MG; 300MGcapsule · oralAPOTEX INCDiscontinued23 Jan 2003
AXID15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · oralBRAINTREEDiscontinued25 May 2004
NIZATIDINE15MG/MLsolution · oralAMNEAL PHARMSDiscontinued18 Nov 2009
NIZATIDINE150MG; 300MGcapsule · oralGLENMARK PHARMSDiscontinued15 Jul 2011

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AXID00778338150 MGCAPSULE · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNIZATIDINE 150 MG CAPSULE$0.80421per EA23 Sep 2026
US NADACNIZATIDINE 300 MG CAPSULE$0.79878per EA17 Jun 2026
NHS Drug TariffNizatidine 150mg capsules£76.4130 capsule1 Oct 2026
NHS Drug TariffNizatidine 300mg capsules£133.3330 capsule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for nizatidine →

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.