Regulatory PathRegulatory requirements compared

Active substance

Phenobarbital

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEZABY100MG/VIALpowder · intravenousSUN PHARM INDS INCPrescription17 Nov 2022

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP PHENOBARBITAL0255778915 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP PHENOBARBITAL0255779730 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP PHENOBARBITAL0255780060 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP PHENOBARBITAL02557819100 MGTABLET · ORALJAMP PHARMA CORPORATION
PHENOBARBITAL SODIUM INJECTION, USP0230408230 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
PHENOBARBITAL SODIUM INJECTION, USP02304090120 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
PMS-PHENOBARBITAL0017879915 MGTABLET · ORALPHARMASCIENCE INC
PMS-PHENOBARBITAL0017880230 MGTABLET · ORALPHARMASCIENCE INC
PMS-PHENOBARBITAL0017881060 MGTABLET · ORALPHARMASCIENCE INC
PMS-PHENOBARBITAL00178829100 MGTABLET · ORALPHARMASCIENCE INC
PMS-PHENOBARBITAL ELIXIR006455755 MG / MLSOLUTION · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPHENOBARBITAL 100 MG TABLET$0.21266per EA23 Sep 2026
US NADACPHENOBARBITAL 15 MG TABLET$0.07659per EA23 Sep 2026
US NADACPHENOBARBITAL 16.2 MG TABLET$0.0559per EA23 Sep 2026
US NADACPHENOBARBITAL 20 MG/5 ML ELIX$0.04697per ML23 Sep 2026
US NADACPHENOBARBITAL 20 MG/5 ML SOLN$0.04697per ML23 Sep 2026
US NADACPHENOBARBITAL 30 MG TABLET$0.14164per EA23 Sep 2026
US NADACPHENOBARBITAL 32.4 MG TABLET$0.07856per EA23 Sep 2026
US NADACPHENOBARBITAL 60 MG TABLET$0.18086per EA23 Sep 2026
US NADACPHENOBARBITAL 64.8 MG TABLET$0.10159per EA23 Sep 2026
US NADACPHENOBARBITAL 97.2 MG TABLET$0.11769per EA23 Sep 2026
NHS Drug TariffPhenobarbital 15mg tablets£6.4428 tablet1 Oct 2026
NHS Drug TariffPhenobarbital 15mg/5ml elixir£83.00500 ml1 Oct 2026
NHS Drug TariffPhenobarbital 200mg/1ml solution for injection ampoules£149.1510 ampoule1 Oct 2026
NHS Drug TariffPhenobarbital 30mg tablets£1.7628 tablet1 Oct 2026
NHS Drug TariffPhenobarbital 30mg/1ml solution for injection ampoules£181.7410 ampoule1 Oct 2026
NHS Drug TariffPhenobarbital 60mg tablets£3.6428 tablet1 Oct 2026
NHS Drug TariffPhenobarbital 60mg/1ml solution for injection ampoules£197.0110 ampoule1 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)

  • 5.1.1. Antiseizure medicines · core
    Status epilepticus; Epilepsy or seizures
    Parenteral > General injections > IV: 200 mg per mL (phenobarbital sodium); 30 mg per mL (phenobarbital sodium) (EMLc); 60 mg per mL (phenobarbital sodium) (EMLc) | Oral > Liquid: 15 mg per 5 mL | Oral > Solid > tablet: 15 mg; 30 mg; 60 mg; 100 mg

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.