Prescription medicine
Phenobarbital Brand names: Sezaby
Phenobarbital (Sezaby) is a prescription medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $0.213 per phenobarbital 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- A presentation discontinued
- DEA Schedule IV
Check it at the source: the phenobarbital FDA label on DailyMed (effective August 27, 2026); the NDA 215910 record on Drugs@FDA; every phenobarbital label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSedative Anticonvulsant – For the treatment of generalized and partial seizures.
Forms and strengths
- 100 mg
Injection.
On the market
- Earliest approval on file
- November 17, 2022 Sezaby, Sun Pharm Inds Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 7, 2042 Sezaby injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.213 per tablet Phenobarbital 100 mg tablet
- Shortage (FDA)
- None current 8 past records
- Recalls by its makers (FDA)
- 9 since 2013 2 Class I among all firms' recalls; latest April 14, 2022; 6 more by firms not listed as its makers
- FAERS reports
- 402 through July 30, 2026
What is phenobarbital used for?
From the label: indications and usageSedative Anticonvulsant – For the treatment of generalized and partial seizures.
Conditions named in the indications of phenobarbital's FDA labels, with every medicine labeled for each:
From other phenobarbital labelsSeizures and epilepsy: INDICATIONS AND USAGE Sedative Anticonvulsant – For the treatment of generalized and partial seizures.
Source: FDA drug label (Phenobarbital), Chartwell RX, LLC, effective August 27, 2026 (SPL set 74428144-fb24-40a5-a670-3b876e2d116c), via openFDA; the full label on DailyMed
Is there a generic for phenobarbital (Sezaby)?
No generic phenobarbital is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Sezaby injection, the last expiring on April 7, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phenobarbital (Sezaby)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.213 per Phenobarbital 100 mg tablet, down 18% from $0.260 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Phenobarbital 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Phenobarbital 100 mg tablet | Generic | $0.213 per tablet | $6.38 | -18% |
| Phenobarbital 15 mg tablet | Generic | $0.0766 per tablet | $2.30 | -7% |
| Phenobarbital 16.2 mg tablet | Generic | $0.0559 per tablet | $1.68 | -19% |
| Phenobarbital 20 mg/5 mL elix | Generic | $0.047 per mL | n/a | +12% |
| Phenobarbital 20 mg/5 mL solution | Generic | $0.047 per mL | n/a | +12% |
| Phenobarbital 30 mg tablet | Generic | $0.142 per tablet | $4.25 | -15% |
| Phenobarbital 32.4 mg tablet | Generic | $0.0786 per tablet | $2.36 | -47% |
| Phenobarbital 60 mg tablet | Generic | $0.181 per tablet | $5.43 | -15% |
| Phenobarbital 64.8 mg tablet | Generic | $0.102 per tablet | $3.05 | -32% |
| Phenobarbital 97.2 mg tablet | Generic | $0.118 per tablet | $3.53 | -53% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is phenobarbital in shortage?
No phenobarbital presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 8 records are all marked to be discontinued, the latest updated October 31, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Phenobarbital, Tablet, 16.2 mg (NDC 0603-5165-21) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 16.2 mg (NDC 0603-5165-32) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 32.4 mg (NDC 0603-5166-21) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 32.4 mg (NDC 0603-5166-32) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 64.8 mg (NDC 0603-5167-21) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 64.8 mg (NDC 0603-5167-32) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 97.2 mg (NDC 0603-5168-21) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
| Phenobarbital, Tablet, 97.2 mg (NDC 0603-5168-32) | Endo Pharmaceuticals, Inc. | To Be Discontinued | October 31, 2025 |
Every phenobarbital presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has phenobarbital been recalled?
The FDA's Enforcement Report lists 15 recalls naming phenobarbital since 2013: 2 Class I (the most serious), 12 Class II, 1 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of phenobarbital and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 14, 2022 | Class III | Monarch PCM, LLC | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content |
| March 14, 2022 | Class II | Vitae Enim Vitae Scientific, Inc. not a listed maker | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be … |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| March 25, 2019 | Class II | Lohxa LLC | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. |
| April 20, 2017 | Class I | C. O. Truxton | Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets |
| April 20, 2017 | Class I | C. O. Truxton | Labeling: Label Mixup; potentially mislabeled |
| October 3, 2016 | Class II | West-Ward Pharmaceuticals Corp. not a listed maker | Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the phenobarbital label say about other medicines?
The phenobarbital label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name phenobarbital. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | warnings and precautions | Additionally, consider alternatives to structurally similar drugs such as carboxamides (e.g., carbamazepine) and hydantoins (e.g., phenytoin) in these same patients. |
| Phenytoin | warnings and precautions | Additionally, consider alternatives to structurally similar drugs such as carboxamides (e.g., carbamazepine) and hydantoins (e.g., phenytoin) in these same patients. |
Other labels that name phenobarbital
- Aminophylline
- Apremilast
- Atazanavir
- Buprenorphine
- Bupropion
- Buspirone
- Cabotegravir
- Cabozantinib
- Caffeine
- Calcifediol
- Calcitriol
- Canagliflozin
- Carmustine
- Cholestyramine
- Clarithromycin
- Clomipramine
- Clonazepam
- Cobicistat
- Dapsone
- Darunavir
- Deferasirox
- Diazepam
- Divalproex
- Dolutegravir
- Donepezil and memantine
- Doravirine
- Doxercalciferol
- Dronedarone
- Drospirenone and ethinyl estradiol and levomefolate
- Efavirenz
- Enzalutamide
- Erlotinib
- Estradiol
- Estrogens conjugated
- Etravirine
- Exemestane
- Fenoprofen
- Folic acid
- Fosamprenavir
- Ganaxolone
- Granisetron
- Hydrocortisone
- Irinotecan
- Itraconazole
- Lamotrigine
- Lenacapavir
- Letermovir
- Leucovorin
- Levoleucovorin
- Levothyroxine
- Liothyronine
- Lopinavir and ritonavir
- Maribavir
- Methadone
- Methsuximide
- Methylprednisolone
- Metronidazole
- Mifepristone
- Nelfinavir
- Nirmatrelvir and ritonavir
- Osilodrostat
- Oxcarbazepine
- Primidone
- Propranolol
- Quinidine
- Quinine
- Ranolazine
- Rilpivirine
- Risperidone
- Roflumilast
- Rufinamide
- Sapropterin
- Selegiline
- Sirolimus
- Sofosbuvir
- Stiripentol
- Tacrolimus
- Tadalafil
- Temsirolimus
- Tenofovir alafenamide
- Theophylline
- Tiagabine
- Ticagrelor
- Tinidazole
- Trabectedin
- Valproic acid
- Verapamil
- Voriconazole
- Warfarin
Source: FDA drug label (Phenobarbital), Chartwell RX, LLC, effective August 27, 2026 (SPL set 74428144-fb24-40a5-a670-3b876e2d116c), via openFDA; the full label on DailyMed
What do FAERS reports show for phenobarbital?
The FDA Adverse Event Reporting System holds 402 reports that list phenobarbital among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 61 are coded as a death and 210 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as phenobarbital?
18 other medicines are given the same way (oral) and in the same FDA class as phenobarbital or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Topiramate | Seizures and epilepsy | 47 labelers | $0.0567 per tablet 100 mg tablet | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Levetiracetam | Seizures and epilepsy | 63 labelers | $0.0736 per tablet 500 mg tablet | No current entry |
| Clonazepam | Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lacosamide | Seizures and epilepsy | 43 labelers | $0.174 per tablet 100 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Brivaracetam | Seizures and epilepsy | 14 labelers | $0.259 per tablet 100 mg tablet | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as phenobarbital
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does phenobarbital compare with medicines for the same use?
1 side-by-side page set phenobarbital beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to phenobarbital
- 18 medicines for the same use
- Phenobarbital side effects
- the label's list beside FAERS reports
- Phenobarbital shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other