Regulatory PathRegulatory requirements compared

Active substance

Metoclopramide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CLOPRAM 10 mg/2 ml solution for injection5 mg/mlSolution for injection · Intramuscular and intravenous use5 AmpouleSAR 9.00Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
PREMOSAN 10 mg injection10 mgInjection · Parenteral use5 AmpouleSAR 9.00Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
PREMOSAN 10 mg tablet10 mgTablet · Oral use20 BlisterSAR 6.70Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
PREMOSAN 10MG10 mgTablet · Oral use200 BlisterSAR 64.15Generic · PrescriptionGULF PHARMACEUTICAL INDUSTIRES- JULPHARValid
PREMOSAN ORAL DROPS 4MG-ML4 mg/mlOral drops · Oral use1 BottleSAR 2.85Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
PREMOSAN SYRUP 5MG-5ML1 mg/mlSyrup · Oral use1 BottleSAR 3.85Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
PRIMPERAN TAB 10MG10 mgTablet · Oral use20 BlisterSAR 6.70NCE · Prescriptionsanofi-aventisValid
METAGLIZ 10 MG TAB10 mgTablet · Oral use100 BlisterSAR 13.65Generic · PrescriptionALMIRALL PRODES PHARMA S.A.Withdrawn by MAH · Not Marketed
METAGLIZ 10MG-5ML SOLUTION2 mg/mlSyrup · Oral use1 BottleSAR 4.70Generic · PrescriptionALMIRALL PRODES PHARMA S.A.Withdrawn by MAH · Not Marketed
METOSIL TAB 10MG10 mgFilm-coated tablet · Oral use20 BlisterSAR 5.45Generic · PrescriptionSPIMACO ADDWAEIHInvalid · Not Marketed
PRIMPERAN 5MG-ML 2ML-AMP.5 mgSolution · Parenteral use6 AmpouleSAR 11.35NCE · Prescriptionsanofi-aventisInvalid · Not Marketed
PRIMPERAN ADULT SUPP. 20MG20 mgSuppository · Rectal use6 BlisterSAR 6.75Generic · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
PRIMPERAN CHILDREN SUPP.10 mgSuppository · Rectal use6 BlisterSAR 4.55Generic · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
PRIMPERAN DROPS 0.1MG-DROP0.1 mgSolution · Oral use1 BottleSAR 5.90NCE · Prescriptionsanofi-aventisWithdrawn by MAH · Not Marketed
PYLOMID 10MG TAB10 mgTablet · Oral use30 BlisterSAR 3.25Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
RIAMIDE1 mg/mlSyrup · Oral use1 BottleSAR 2.80Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD); MENSTRUAL DISORDERS; MIGRAINE/ HEADACHE; NAUSEA AND VOMITING IN CANCER; PEPTIC ULCER; RENAL AND URETERIC STONES; VERTIGO - MOTION SICKNESS; VERTIGO -BENIGN PAROXYSMAL POSITIONAL VERTIGO AND ACUTE VESTIBULAR NEURONITIS OR LABYRINTHITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
REGLANEQ 10MG BASE; EQ 5MG BASEtablet · oralANI PHARMSPrescription30 Dec 1980
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralTEVAPrescription29 Jul 1985
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASE; EQ 5MG BASEtablet · oralAIPING PHARM INCPrescription30 Jan 1990
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLinjectable · injectionHOSPIRAPrescription17 Jan 1991
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLsolution · oralPAI HOLDINGSPrescription28 May 1991
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLinjectable · injectionTEVA PHARMS USAPrescription27 Nov 1991
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASEtablet · oralTEVAPrescription15 Jun 1993
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/5MLsolution · oralANI PHARMSPrescription25 Jun 1993
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE; EQ 10MG BASEtablet · oralSTRIDES PHARMA INTLPrescription28 Aug 2006
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE; EQ 10MG BASEtablet · oralIPCA LABS LTDPrescription12 Jun 2008
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLinjectable · injectionFRESENIUS KABI USAPrescription19 Apr 2013
METOCLOPRAMIDEEQ 5MG BASE/MLinjectable · injectionAVET LIFESCIENCESPrescription20 Dec 2013
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE; EQ 10MG BASEtablet, orally disintegrating · oralNOVEL LABS INCPrescription15 Aug 2014
GIMOTIEQ 15MG BASE/SPRAYspray, metered · nasalQOL MEDCLPrescription19 Jun 2020
METOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE/MLinjectable · injectionBAXTER HLTHCARE CORPPrescription11 Sep 2026
REGLANEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionHIKMA PHARMSDiscontinued7 Feb 1979
REGLANEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · oralROBINS AHDiscontinued25 Mar 1983
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralSTRIDES PHARMA INTLDiscontinued17 Oct 1985
CLOPRA-"YELLOW"EQ 10MG BASEtablet · oralQUANTUM PHARMICSDiscontinued28 Oct 1985
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralWATSON LABSDiscontinued22 Jan 1986
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASE/2MLinjectable · injectionLYPHOMEDDiscontinued24 Jan 1986
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralSCHERINGDiscontinued2 Feb 1987
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralMUTUAL PHARMDiscontinued10 Feb 1987
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASE/2MLinjectable · injectionSMITH AND NEPHEWDiscontinued2 Mar 1987
METOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASEtablet · oralSUPERPHARMDiscontinued26 Jun 1987

42 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MAR-METOCLOPRAMIDE025177955 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
METOCLOPRAMIDE HYDROCHLORIDE INJECTION021854315 MG / MLLIQUID · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
METOCLOPRAMIDE HYDROCHLORIDE INJECTION025317475 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARBAXTER CORPORATION
METOCLOPRAMIDE HYDROCHLORIDE INJECTION025373975 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARJAMP PHARMA CORPORATION
METOCLOPRAMIDE INJECTION USP022435635 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULAROMEGA LABORATORIES LIMITED
PMS-METOCLOPRAMIDE HYDROCHLORIDE INJECTION025107905 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSPHARMASCIENCE INC
PMS-METOCLOPRAMIDE ORAL SOLUTION022304335 MG / 5 MLSOLUTION · ORALPHARMASCIENCE INC
PMS-METOCLOPRAMIDE TABLETS022304315 MGTABLET · ORALPHARMASCIENCE INC
PRZ-METOCLOPRAMIDE025487475 MGTABLET · ORALPHARMARIS CANADA INC
PRZ-METOCLOPRAMIDE0254875510 MGTABLET · ORALPHARMARIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMETOCLOPRAMIDE 10 MG TABLET$0.04394per EA23 Sep 2026
US NADACMETOCLOPRAMIDE 10 MG/2 ML VIAL$0.52896per ML22 Jul 2026
US NADACMETOCLOPRAMIDE 5 MG TABLET$0.0358per EA23 Sep 2026
US NADACMETOCLOPRAMIDE 5 MG/5 ML SOLN$0.12569per ML23 Sep 2026
NHS Drug TariffMetoclopramide 10mg tablets£0.7428 tablet1 Oct 2026
NHS Drug TariffMetoclopramide 10mg/2ml solution for injection ampoules£5.1910 ampoule1 Oct 2026
NHS Drug TariffMetoclopramide 5mg tablets£3.7528 tablet1 Oct 2026
NHS Drug TariffMetoclopramide 5mg/5ml oral solution sugar free£6.01150 ml1 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)

  • 2.3. Medicines for other common symptoms in palliative care · core
    Palliative care
    Oral > Liquid: 5 mg per 5 mL | Oral > Solid: 10 mg (hydrochloride) | Parenteral > General injections > unspecified: 5 mg per mL in 2 mL ampoule (hydrochloride)
  • 17.2. Antiemetic medicines · core
    Nausea or vomiting
    Oral > Liquid: 5 mg per 5 mL (EMLc) | Oral > Solid: 10 mg (scored) (hydrochloride) | Parenteral > General injections > unspecified: 5 mg per mL in 2 mL ampoule (hydrochloride)

Safety signals and safety-related labeling changes

  • US FDA 9 Feb 2026 GIMOTI — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Feb 2026 REGLAN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Feb 2026 REGLAN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 28 Feb 2019 METOZOLV ODT — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • MHRA 11 Dec 2014 Metoclopramide: risk of neurological adverse effects
    Restricted dose and duration of use.

All safety entries for metoclopramide →

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.