Regulatory PathRegulatory requirements compared

Active substance

Calcitriol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Rocaltrol0.25 µgCapsule, soft · Oral use100 BlisterSAR 136.20NCE · PrescriptionAtnahs Pharma UK LimitedValid
CALCIJEX 1MCG-ML I.V. AMP1 µ/mlSolution · Intravenous use1 AmpouleSAR 22.50NCE · PrescriptionAbbott LaboratoriesWithdrawn by MAH · Not Marketed
CALCIJEX 2MCG-ML AMP2 µ/mlSolution · Intravenous use1 AmpouleSAR 36.25NCE · PrescriptionAbbott LaboratoriesWithdrawn by MAH · Not Marketed
ROCALTROL CAP 0.25MCG0.25 µgCapsule · Oral use30 BlisterSAR 53.75NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
ROCALTROL CAP 0.5MCG0.5 µgCapsule · Oral use30 BlisterSAR 94.80NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HYPERPARATHYRODISM

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

ProductStrengthForm · routeApplicantStatusFirst approved
ROCALTROL0.25MCG; 0.5MCGcapsule · oralESJAY PHARMAPrescription17 Aug 1978
ROCALTROL1MCG/MLsolution · oralESJAY PHARMAPrescription20 Nov 1998
CALCITRIOL0.25MCG; 0.5MCGcapsule · oralTEVAPrescription12 Oct 2001
CALCITRIOL1MCG/MLsolution · oralHIKMA PHARMSPrescription18 Jul 2003
CALCITRIOL0.25MCGcapsule · oralHIKMA PHARMSPrescription27 Mar 2006
CALCITRIOL0.001MG/MLinjectable · injectionLONG GROVE PHARMSPrescription29 Jan 2008
VECTICAL3MCG/GMointment · topicalGALDERMA LABS LPPrescription23 Jan 2009
CALCITRIOL0.25MCG; 0.5MCGcapsule · oralBIONPHARMAPrescription24 May 2013
CALCITRIOL0.25MCG; 0.5MCGcapsule · oralONESOURCE SPECIALTYPrescription12 Dec 2014
CALCITRIOL0.5MCG; 0.25MCGcapsule · oralAMNEAL PHARMSPrescription14 Jun 2017
CALCITRIOL1MCG/MLsolution · oralRISINGPrescription21 Nov 2018
CALCITRIOL0.001MG/MLinjectable · injectionGLANDPrescription3 Feb 2020
CALCITRIOL1MCG/MLsolution · oralANDA REPOSITORYPrescription28 Jul 2023
CALCITRIOL0.25MCG; 0.5MCGcapsule · oralHUMANWELL PURACAPPrescription27 Feb 2026
CALCIJEX0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionABBVIEDiscontinued25 Sep 1986
CALCITRIOL0.001MG/ML; 0.002MG/MLinjectable · injectionFRESENIUS KABI USADiscontinued31 Dec 2002
CALCITRIOL0.001MG/ML; 0.002MG/MLinjectable · injectionFRESENIUS MEDCLDiscontinued20 Feb 2003
CALCITRIOL0.001MG/ML; 0.002MG/MLinjectable · injectionTEVA PARENTERALDiscontinued31 Mar 2003
CALCITRIOL0.001MG/MLinjectable · injectionROCKWELL MEDCLDiscontinued17 Sep 2003
CALCITRIOL0.001MG/ML; 0.002MG/MLinjectable · injectionAM REGENTDiscontinued26 Sep 2003
CALCITRIOL0.001MG/ML; 0.002MG/MLinjectable · injectionHOSPIRADiscontinued16 Jan 2004
CALCITRIOL0.001MG/MLinjectable · injectionSAGENT PHARMSDiscontinued8 Feb 2006
CALCITRIOL0.002MG/MLinjectable · injectionLONG GROVE PHARMSDiscontinued29 Jan 2008
CALCITRIOL0.25MCG; 0.5MCGcapsule · oralSUN PHARMDiscontinued21 Feb 2019

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CALCITRIOL-ODAN024316370.25 MCGCAPSULE · ORALODAN LABORATORIESLTD
CALCITRIOL-ODAN024316450.5 MCGCAPSULE · ORALODAN LABORATORIESLTD
ROCALTROL004818150.5 MCGCAPSULE · ORALSEARCHLIGHT PHARMA INC
ROCALTROL004818230.25 MCGCAPSULE · ORALSEARCHLIGHT PHARMA INC
TARO-CALCITRIOL024857100.25 MCGCAPSULE · ORALTARO PHARMACEUTICALS INC
TARO-CALCITRIOL024857290.5 MCGCAPSULE · ORALTARO PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCALCITRIOL 0.25 MCG CAPSULE$0.15317per EA7 Oct 2026
US NADACCALCITRIOL 0.5 MCG CAPSULE$0.23399per EA7 Oct 2026
US NADACCALCITRIOL 1 MCG/ML SOLUTION$6.60188per ML23 Sep 2026
NHS Drug TariffCalcitriol 250nanogram capsules£18.04100 capsule1 Oct 2026
NHS Drug TariffCalcitriol 3micrograms/g ointment£18.06100 gram1 Oct 2026
NHS Drug TariffCalcitriol 500nanogram capsules£32.25100 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.

WHO WHO Model List of Essential Medicines (2025)

  • 13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · core
    Therapeutic equivalent to calcipotriol for Psoriasis of unspecified type

Safety signals and safety-related labeling changes

  • US FDA 17 Jul 2020 VECTICAL — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for calcitriol →

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.