Phenobarbital Sodium

Treats neonatal seizures in term and preterm infants. Sold as Sezaby. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Phenobarbital Sodium (sold as Sezaby), first approved Nov 17, 2022, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 17, 2022
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $70K
Orphan exclusivity until: Nov 17, 2029

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Phenobarbital Sodium	Part D	$70K	-26%	44

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PHENOBARBITAL 100 MG TABLET: $0.201 per unitGeneric · -17% in a year
PHENOBARBITAL 15 MG TABLET: $0.084 per unitGeneric · +5% in a year
PHENOBARBITAL 16.2 MG TABLET: $0.059 per unitGeneric · -13% in a year
PHENOBARBITAL 20 MG/5 ML ELIX: $0.053 per MLGeneric · +26% in a year
PHENOBARBITAL 20 MG/5 ML SOLN: $0.053 per MLGeneric · +26% in a year
PHENOBARBITAL 30 MG TABLET: $0.126 per unitGeneric · -24% in a year
PHENOBARBITAL 32.4 MG TABLET: $0.077 per unitGeneric · -46% in a year
PHENOBARBITAL 60 MG TABLET: $0.171 per unitGeneric · -22% in a year
PHENOBARBITAL 64.8 MG TABLET: $0.101 per unitGeneric · -37% in a year
PHENOBARBITAL 97.2 MG TABLET: $0.119 per unitGeneric · -49% in a year

Orphan Designations (FDA)

7 designations, 1 approved for the designated use; see all orphan designations

Treatment of neonatal seizuresHikma Pharmaceuticals USA, Inc. · designated Sep 30, 2020
Treatment of neonatal seizuresNivagen Pharmaceuticals, Inc. · designated Feb 27, 2020
Treatment of Neonatal seizuresAccord Healthcare Inc. · designated Feb 26, 2020
Treatment of status epilepticusAccord Healthcare Inc. · designated Feb 26, 2020
Treatment of neonatal seizuresSun Pharmaceutical Industries, Inc. · designated Oct 2, 2019 · approved Nov 17, 2022 · exclusive to Nov 17, 2029
Treatment of neonatal seizuresGenus Lifesciences · designated Mar 28, 2018
Treatment of neonatal seizuresRenaissance SSA, LLC · designated Oct 25, 2017 · withdrawn

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Noberbar, new approvalA drug with a new route of administration indicated for the treatment of 1) neonatal seizures and 2) status epilepticus. · Nobelpharma Co., Ltd. · Oct 16, 2008

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal SeizuresNeonatal Seizure · Sun Pharma Advanced Research Company Limited	Phase 4	Not yet recruiting	Nov 6, 2026
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In NeonatesJaundice, Neonatal · Rubab Fatima	Phase 4	Not yet recruiting	Aug 19, 2026
Treatment of Seizures in Neonate With HIENeonatal Seizures, HIE - Hypoxic - Ischemic Encephalopathy · Mansoura University	Phase 4	Not yet recruiting	Dec 16, 2025
Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's HospitalNeonatal Convulsions, Newborn Seizure Disorders · Assiut University	—	Not yet recruiting	Dec 10, 2025
Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged SeizuresSeizure · Ministry of Health and Sports, Myanmar	Not applicable	Recruiting	Aug 1, 2025
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal SeizuresNeonatal Seizure, Neonatal Encephalopathy · University of California, San Diego	Phase 2	Recruiting	Nov 9, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Nov 17, 2022	SezabyNDA 215910 · New dosage form	Sun Pharm Inds Inc	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA