Active substance
Phenytoin
- SFDA 8
- US FDA 45
- Health Canada 7
- US price lines 8
- NHS prices 7
- WHO EML 1
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| EPANUTIN | 100 mg | Capsule · Oral use | 100 Tablet Container | SAR 28.10 | Generic · Prescription | Viatris AB | Valid |
| EPANUTIN SUSP 30MG-5ML | 6 mg/ml | Oral suspension · Oral use | 1 Bottle | SAR 7.60 | NCE · Prescription | UPJOHN UK LIMITED | Valid |
| FENTEX 50MG/ML SOLUTION FOR INJECTION | 50 mg/ml | Solution for injection · Intramuscular and intravenous use | 10 Vial | SAR 128.50 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| PHENTOLEP 50MG-ML AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 71.40 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| DINTOINA TAB 100MG | 100 mg | Tablet · Oral use | 30 Blister | SAR 4.40 | NCE · Prescription | RECORDATI | Invalid · Not Marketed |
| EPANUTIN R.M 250MG PARENTRAL AMP | 250 mg | Injection · Intravenous use | 10 Ampoule | SAR 176.60 | NCE · Prescription | PARK-DAVIS | Withdrawn by MAH · Not Marketed |
| EPANUTIN SUSP 30MG-5ML | 6 mg/ml | Oral suspension · Oral use | 1 Bottle | SAR 7.60 | NCE · Prescription | PARK-DAVIS | Withdrawn by MAH · Not Marketed |
| PHENYTOIN 250MG-5ML AMP | 50 mg/ml | Injection · Intravenous use | 5 Ampoule | SAR 79.35 | Generic · Prescription | Pfizer Australia Pty LTD | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
FOCAL SEIZURES
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DILANTIN-125 | 125MG/5ML | suspension · oral | VIATRIS | Prescription | 6 Jan 1953 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 16 Jul 1975 |
| DILANTIN | 30MG EXTENDED; 100MG EXTENDED | capsule · oral | VIATRIS | Prescription | 27 Aug 1976 |
| DILANTIN | 50MG | tablet, chewable · oral | PHARMACIA | Prescription | 26 Feb 1979 |
| PHENYTEK | 200MG EXTENDED; 300MG EXTENDED | capsule · oral | MYLAN | Prescription | 28 Dec 1998 |
| PHENYTOIN | 125MG/5ML | suspension · oral | TARO | Prescription | 8 Mar 2004 |
| EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | capsule · oral | TARO | Prescription | 5 Sep 2006 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | ACELLA | Prescription | 13 Sep 2006 |
| EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | capsule · oral | AMNEAL PHARMS NY | Prescription | 12 Nov 2008 |
| PHENYTOIN | 50MG | tablet, chewable · oral | RISING | Prescription | 26 Dec 2012 |
| PHENYTOIN | 50MG | tablet, chewable · oral | TARO | Prescription | 17 Apr 2014 |
| PHENYTOIN | 50MG | tablet, chewable · oral | EPIC PHARMA LLC | Prescription | 28 Nov 2014 |
| EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | capsule · oral | AUROBINDO PHARMA | Prescription | 10 Jun 2015 |
| DILANTIN-30 | 30MG/5ML | suspension · oral | VIATRIS | Discontinued | 6 Jan 1953 |
| DILANTIN | 50MG/ML | injectable · injection | PARKE DAVIS | Discontinued | 1 Mar 1956 |
| DIPHENYLAN SODIUM | 30MG PROMPT; 100MG PROMPT | capsule · oral | CHARTWELL MOLECULAR | Discontinued | 3 Dec 1976 |
| PHENYTOIN SODIUM | 100MG PROMPT | capsule · oral | PHARMERAL | Discontinued | 15 Apr 1977 |
| PROMPT PHENYTOIN SODIUM | 100MG PROMPT | capsule · oral | WATSON LABS | Discontinued | 3 Mar 1978 |
| PROMPT PHENYTOIN SODIUM | 100MG PROMPT | capsule · oral | ANI PHARMS | Discontinued | 6 Apr 1978 |
| PHENYTOIN SODIUM | 100MG PROMPT | capsule · oral | WATSON LABS | Discontinued | 11 May 1979 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | FRESENIUS KABI USA | Discontinued | 31 May 1985 |
| EXTENDED PHENYTOIN SODIUM | 100MG EXTENDED | capsule · oral | ANI PHARMS | Discontinued | 18 Dec 1986 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | HOSPIRA | Discontinued | 17 Mar 1987 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | MARSAM PHARMS LLC | Discontinued | 13 Oct 1987 |
| PHENYTOIN SODIUM | 50MG/ML | injectable · injection | HOSPIRA | Discontinued | 18 Dec 1987 |
20 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DILANTIN | 00022772 | 30 MG | CAPSULE · ORAL | BGP PHARMA ULC |
| DILANTIN | 00022780 | 100 MG | CAPSULE · ORAL | BGP PHARMA ULC |
| DILANTIN INFATABS | 00023698 | 50 MG | TABLET (CHEWABLE) · ORAL | BGP PHARMA ULC |
| PHENYTOIN SODIUM | 02460912 | 100 MG | CAPSULE · ORAL | AA PHARMA INC |
| PHENYTOIN SODIUM INJECTION USP | 00780626 | 50 MG / ML | LIQUID · INTRAVENOUS; INTRAMUSCULAR | SANDOZ CANADA INCORPORATED |
| PHENYTOIN SODIUM INJECTION USP | 02431378 | 50 MG / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | HIKMA CANADA LIMITED |
| TARO-PHENYTOIN | 02250896 | 125 MG / 5 ML | SUSPENSION · ORAL | TARO PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DILANTIN 100 MG CAPSULE | $1.73861 | per EA | 30 Sep 2026 |
| US NADAC | DILANTIN 30 MG CAPSULE | $1.49889 | per EA | 23 Sep 2026 |
| US NADAC | DILANTIN 50 MG INFATAB | $1.57665 | per EA | 23 Sep 2026 |
| US NADAC | PHENYTEK 200 MG CAPSULE | $1.4026 | per EA | 23 Sep 2026 |
| US NADAC | PHENYTEK 300 MG CAPSULE | $2.09778 | per EA | 23 Sep 2026 |
| US NADAC | PHENYTOIN 125 MG/5 ML SUSP | $0.07485 | per ML | 23 Sep 2026 |
| US NADAC | PHENYTOIN 50 MG INFATAB CHEW | $0.20122 | per EA | 23 Sep 2026 |
| US NADAC | PHENYTOIN 50 MG TABLET CHEW | $0.20122 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Phenytoin 30mg/5ml oral suspension | £4.27 | 500 ml | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin 50mg chewable tablets | £13.18 | 200 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin sodium 100mg capsules | £9.14 | 84 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin sodium 100mg tablets | £10.18 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin sodium 25mg capsules | £13.08 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin sodium 300mg capsules | £16.43 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Phenytoin sodium 50mg capsules | £7.07 | 28 capsule | 1 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
Epilepsy or seizures
Oral > Liquid: 30 mg per 5 mL (phenytoin) | Parenteral > General injections > unspecified: 50 mg per mL in vial (phenytoin sodium) | Oral > Solid > tablet: 50 mg (phenytoin) (chewable) | Oral > Solid > dosage form: 25 mg (phenytoin sodium); 50 mg (phenytoin sodium); 100 mg (phenytoin sodium)
Safety signals and safety-related labeling changes
- US FDA 3 Mar 2022 DILANTIN-125 — 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 - US FDA 31 Oct 2017 DILANTIN — 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 Phenytoin: risk of Stevens-Johnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin
If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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.