Details of the Drug Formulations

General Information of Drug (ID: DMNOKBV)

• Drug Name: Phenytoin Drug Info
• Synonyms: Aleviatin; Antisacer; Auranile; Causoin; Citrullamon; Citrulliamon; Comital; Comitoina; Convul; Danten; Dantinal; Dantoinal; Dantoine; Denyl; Difenilhidantoina; Difenin; Difetoin; Difhydan; Dihycon; Dihydantoin; Dilabid; Dilantin; Dilantine; Dillantin; Dintoin; Dintoina; Diphantoin; Diphedal; Diphedan; Diphenat; Diphenin; Diphenine; Diphentoin; Diphentyn; Diphenylan; Diphenylhydantoin; Diphenylhydantoine; Diphenylhydatanoin; Ditoinate; Ekko; Elepsindon; Enkelfel; Epamin; Epanutin; Epelin; Epifenyl; Epihydan; Epilantin; Epinat; Epised; Eptal; Eptoin; Fenitoin; Fenitoina; Fentoin; Fenylepsin; Fenytoine; Hidan; Hidantal; Hidantilo; Hidantina; Hidantomin; Hindatal; Hydantal; Hydantin; Hydantoinal; Hydantol; Idantoil; Idantoin; Iphenylhydantoin; Kessodanten; Labopal; Lehydan; Lepitoin; Lepsin; Minetoin; Neosidantoina; Novantoina; Novophenytoin; Oxylan; PHENYTEK; Phanantin; Phanatine; Phenatine; Phenatoine; Phenhydan; Phenhydanin; Phenitoin; Phentoin; Phentytoin; Phenytex; Phenytoine; Phenytoinum; Ritmenal; Saceril; Sanepil; Silantin; Sinergina; Sodanthon; Sodantoin; Sodanton; Solantin; Solantoin; Solantyl; Sylantoic;TOIN; Tacosal; Thilophenyl; Zentronal; Zentropil; Component of Mebroin; Dantoinal klinos; Difenilhidantoina [Spanish]; Dihydan toin; Dilantin acid; Diphenylhydantoine [French]; Ekko capsules; Elepsi ndon; Epdantoin Simple; Epdantoine simple; Epilan D; Extended Phenytoin Sodium; Fen toin; Fenantoin Mn Pharma; Fenidantoin s; Fenytoin Dak; Hidantina senosian; Hidantina vitoria; Ictalis simp le; Ictalis simple; Om hidantoina simple; Phenat ine; Phenytoin AWD; Sodium Diphenylhydantoinate; Taco sal; Toin unicelles; CL12003; D 4007; D4007_SIGMA; Didan TDC 250; Epasmir 5; IFLab1_000214; DILANTIN-30; DPH (VAN); Di-Hydan; Di-Lan; Di-Phetine; Dilantin (TN); Dilantin Infatabs (TN); Dilantin Kapseals (TN); Dilantin-125; Diphenylhydantoin (VAN); Epanutin (TN); Epasmir (5); Epilan-D; Eptoin (TN); Fenidantoin (s); Fenitoina [INN-Spanish]; Neos-Hidantoina; Om-Hydantoine; PHENYTOIN SODIUM, EXTENDED; Phenytek (TN); Phenytoin (PHN); Phenytoin-Gerot; Phenytoine [INN-French]; Phenytoinum [INN-Latin]; Di-Lan (VAN); Didan-tdc-250; Gerot-epilan-D; PHENYTOIN (5,5-DIPHENYLHYDANTOIN); Phenytoin (JP15/USP/INN); Phenytoin [USAN:INN:BAN:JAN]; Hydantoin, 5,5-diphenyl-(8CI); 2,4-Imidazolidinedione, 5,5-diphenyl-(9CI); 2-hydroxy-5,5-diphenyl-3,5-dihydro-4H-imidazol-4-one; 5,5-DIPHENYLHYDANTOIN; 5,5-Diphenyl-2,4-imidazolidinedione; 5,5-Diphenyl-imidazolidine-2,4-dione; 5,5-Diphenylhydantoin (IUPAC); 5,5-Diphenylhydantoin (phenytoin); 5,5-Diphenylimidazolidin-2,4-dione; 5,5-Dwufenylohydantoina; 5,5-Dwufenylohydantoina [Polish]; 5,5-diphenylimidazolidine-2,4-dione

Indication

Disease Entry	ICD 11	Status	REF
Epilepsy	8A60-8A68	Approved	[1]
Epilepsy with generalized tonic-clonic seizures		Approved	[2]
Focal epilepsy		Approved	[2]
Primary motor cortex epilepsy		Approved	[2]

• Therapeutic Class: Anticonvulsants
• Cross-matching ID:
  PubChem CID: 1775
  ChEBI ID: CHEBI:8107
  CAS Number: 57-41-0
  TTD ID: D0E4DW
  VARIDT ID: DR00431
  INTEDE ID: DR1282
  ACDINA ID: D00529

Full List of Drug Formulations Containing This Drug

Phenytoin 100 mg capsule

Company	Formulation ID	FDA Description
NCS HealthCare of KY, Inc dba Vangard Labs; State of Florida DOH Central Pharmacy	F17233	D&c red no. 28; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Povidone; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 cps at 1%); Shellac
McKesson	F17234	D&c red no. 28; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Povidone; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 mpa.s at 1%); Shellac
Bryant Ranch Prepack	F17235	D&c red no. 28; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 mpa.s at 1%); Povidones; Shellac
Aphena Pharma Solutions-Tennessee; Mylan Pharamceuticals	F17236	D&c red no. 28; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 mpa.s at 1%); Povidones; Shellac
Cardinal Health; Mylan Pharamceuticals	F17237	D&c red no. 28; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; D&c red no. 33; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Hydroxyethyl cellulose (2000 mpa.s at 1%); Microcrystalline cellulose; Povidone, unspecified; Shellac
RemedyRepack; Sun Pharmaceutical Industries; Taro Pharmaceuticals USA	F17220	Methylparaben; Lactose monohydrate; Sodium lauryl sulfate; Butylparaben; D&c yellow no. 10; Benzyl alcohol; Magnesium stearate; Propylparaben; Sodium propionate; Edetate calcium disodium; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Gelatin, unspecified; Hypromellose, unspecified
Cardinal Health; NCS HealthCare of KY, Inc dba Vangard Labs; Physicians Total Care; Rebel Distributors; TYA Pharmaceuticals	F17221	Methylparaben; Lactose monohydrate; Sodium lauryl sulfate; Butylparaben; D&c yellow no. 10; Benzyl alcohol; Magnesium stearate; Propylparaben; Sodium propionate; Edetate calcium disodium; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Gelatin; Hypromelloses
RemedyRepack	F17225	Methylparaben; Lactose monohydrate; Sodium lauryl sulfate; Butylparaben; D&c yellow no. 10; Benzyl alcohol; Magnesium stearate; Propylparaben; Sodium propionate; Edetate calcium disodium; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Gelatin; Hypromelloses
Upsher-Smith Laboratories	F17240	Methylparaben; Lactose monohydrate; Sodium lauryl sulfate; Butylparaben; D&c yellow no. 10; Benzyl alcohol; Magnesium stearate; Propylparaben; Sodium propionate; Edetate calcium disodium; Sucrose; Titanium dioxide; Fd&c red no. 3; Gelatin; Hypromelloses
RedPharm	F17227	Lactitol monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Gelatin; Shellac
A-S Medication Solutions; Bryant Ranch Prepack; Clinical Solutions Wholesale; Sun Pharmaceutical Industries	F17228	Lactitol monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Gelatin; Shellac
Proficient Rx	F17229	Lactitol monohydrate; Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Propylene glycol; Talc; Gelatin, unspecified; Shellac
Contract Pharmacal	F17241	Methylparaben; Lactose monohydrate; Sodium lauryl sulfate; Butylparaben; Benzyl alcohol; Magnesium stearate; Propylparaben; Sodium propionate; Edetate calcium disodium; Talc; Titanium dioxide; Gelatin
PD-Rx Pharmaceuticals; Wockhardt	F17224	D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Magnesium stearate; Magnesium oxide; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Hypromelloses
RemedyRepack; TYA Pharmaceuticals	F17244	D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Magnesium stearate; Magnesium oxide; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Hypromelloses
RemedyRepack	F17245	D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Magnesium stearate; Magnesium oxide; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Hypromelloses
American Health Packaging; Marlex Pharmaceuticals	F17222	D&c red no. 28; D&c red no. 33; Fd&c blue no. 1; Magnesium stearate; Mannitol; Talc; Titanium dioxide; Gelatin; Hydroxypropyl cellulose (type h)
Major Pharmaceuticals	F17223	D&c red no. 28; D&c red no. 33; Fd&c blue no. 1; Magnesium stearate; Mannitol; Talc; Titanium dioxide; Hydroxypropyl cellulose (type h)
AvPAK	F17226	D&c red no. 28; D&c red no. 33; Fd&c blue no. 1; Magnesium stearate; Mannitol; Talc; Titanium dioxide; Hydroxypropyl cellulose (type h)
PD-Rx Pharmaceuticals	F17242	D&c red no. 28; D&c red no. 33; Fd&c blue no. 1; Magnesium stearate; Mannitol; Talc; Titanium dioxide; Gelatin; Hydroxypropyl cellulose
Aurobindo Pharma	F17238	Sodium lauryl sulfate; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Potassium hydroxide; Propylene glycol; Sucrose; Talc; Titanium dioxide; Cellulose, microcrystalline; Gelatin; Hypromellose 2910 (4000 mpa.s); Shellac
Preferred Pharamaceuticals	F17239	Sodium lauryl sulfate; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Potassium hydroxide; Propylene glycol; Sucrose; Talc; Titanium dioxide; Gelatin, unspecified; Hypromellose 2910 (4000 mpa.s); Microcrystalline cellulose; Shellac
A-S Medication Solutions; Cardinal Health; Lake Eire Medical & Surgical Supply DBA Quality Care Products	F17230	D&c red no. 28; Lactose monohydrate; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Gelatin
A-S Medication Solutions; Parke-Davis Div of Pfizer Inc	F17231	D&c red no. 28; Lactose monohydrate; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Gelatin, unspecified
Physicians Total Care	F17243	D&c red no. 28; Lactose monohydrate; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Gelatin
RemedyRepack	F17246	D&c red no. 28; Lactose monohydrate; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Gelatin
Lake Eire Medical & Surgical Supply DBA Quality Care Products	F17232	Lactitol monohydrate; Sodium lauryl sulfate; Magnesium stearate; Talc; Gelatin

Phenytoin 200 mg capsule

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F17247	Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 mpa.s at 1%); Povidones; Shellac
Sun Pharmaceutical Industries	F17248	D&c red no. 28; Lactitol monohydrate; Sodium lauryl sulfate; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Magnesium stearate; Ammonia; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Fd&c red no. 3; Alcohol; Gelatin; Shellac

Phenytoin 300 mg capsule

Company	Formulation ID	FDA Description
Clinical Solutions Wholesale; Mylan Pharamceuticals	F17251	Sodium lauryl sulfate; D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Magnesium stearate; Ferrosoferric oxide; Magnesium oxide; Propylene glycol; Titanium dioxide; Silicon dioxide; Cellulose, microcrystalline; Gelatin; Hydroxyethyl cellulose (2000 mpa.s at 1%); Povidones; Shellac
Sun Pharmaceutical Industries	F17252	Lactitol monohydrate; Sodium lauryl sulfate; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Magnesium stearate; Ammonia; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Alcohol; Gelatin; Shellac

Phenytoin 30 mg capsule

Company	Formulation ID	FDA Description
Avera McKennan Hospital; Kaiser Foundation Hospitals; Physicians Total Care; RemedyRepack	F17249	Lactose monohydrate; D&c yellow no. 10; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Gelatin
Carilion Materials Management; Parke-Davis Div of Pfizer Inc	F17250	Lactose monohydrate; D&c yellow no. 10; Magnesium stearate; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Gelatin, unspecified

Phenytoin 50 mg tablet

Company	Formulation ID	FDA Description
Parke-Davis Div of Pfizer Inc	F17214	D&c yellow no. 10; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Water; Aluminum oxide; Saccharin sodium
American Health Packaging	F17218	Lactose monohydrate; D&c yellow no. 10; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Hypromellose 2208 (100 mpa.s); Saccharin sodium
RemedyRepack	F17219	Lactose monohydrate; D&c yellow no. 10; Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Aluminum oxide; Hypromellose, unspecified; Saccharin sodium
CorePharma	F17216	Fd&c yellow no. 6; Magnesium stearate; Sucrose; Talc; Silicon dioxide; Peppermint; Saccharin sodium; Starch, corn
Cardinal Health; Mylan Pharamceuticals; NCS HealthCare of KY, Inc dba Vangard Labs	F17217	D&c red no. 30; Magnesium stearate; Talc; Silicon dioxide; Starch, corn
Greenstone	F17213	D&c yellow no. 10; Fd&c yellow no. 6; Sucrose; Talc; Aluminum oxide; Saccharin sodium
RemedyRepack	F17215	D&c yellow no. 10; Fd&c yellow no. 6; Sucrose; Talc; Aluminum oxide; Saccharin sodium

References

• [1] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
• [2] Phenytoin FDA Label