Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00525)
Name
Phenobarbital
Synonyms    Click to Show/Hide the Synonyms of This API
phenobarbital; Phenobarbitone; Phenobarbitol; Luminal; Phenylethylbarbiturate; Phenobarbituric acid; Phenylethylmalonylurea; Fenobarbital; Phenemal; Adonal; Phenylethylbarbituric acid; Neurobarb; Phenaemal; Dormiral; Gardenal; Hysteps; Aphenylbarbit; Aphenyletten; Dezibarbitur; Lepinaletten; Lumofridetten; Aephenal; Agrypnal; Amylofene; Barbenyl; Barbiphenyl; Barbipil; Barbivis; Barbonal; Barbophen; Bialminal; Cabronal; Calmetten; Calminal; Cardenal; Codibarbita; Coronaletta; Cratecil; Doscalun; Ensobarb; Ensodorm; Episedal; Epsylone; Eskabarb; Fenbital; Fenylettae; Gardepanyl; Glysoletten; Haplopan; Hennoletten; Hypnaletten; Hypnette; Hypnogen; Hypnolone; Hypnoltol; Liquital; Lixophen; Lubergal; Lubrokal; Lumesettes; Luphenil; Nirvonal; Parkotal; Pharmetten; Phenemalum; Phenobal; Phenobarbyl; Phenoluric; Phenolurio; Phenomet; Phenonyl; Phenoturic; Phenyletten; Phenyral; Polcominal; Promptonal; Sedizorin; Sedonettes; Solfoton; Sombutol; Somnolens; Somnoletten; Somnosan; Spasepilin; Starifen; Starilettae; Teolaxin; Barbita; Bardorm; Bartol; Chinoin; Duneryl; Epanal; Epidorm; Epilol; Etilfen; Euneryl; Fenemal; Fenosed; Haplos; Henotal; Leonal; Lepinal; Linasen; Lumesyn; Luramin; Molinal; Noptil; Sedabar; Sedicat; Sedlyn; Sedofen; Sedonal; Sevenal; Somonal; Seda-Tablinen; Blu-phen; Nova-Pheno; Solu-Barb; Hypno-Tablinetten; Stental Extentabs; Phen-Bar; Phenobarb; Sedophen; Talpheno; Triabarb; Versomnal; 5-Ethyl-5-phenylbarbituric acid; 5-Phenyl-5-ethylbarbituric acid; Tridezibarbitur; Triphenatol; Zadoletten; Barbinal; Barbiphen; Damoral; Dormina; Lefebar; Lephebar; Stental; Teoloxin; Theoloxin; Zadonal; SK-Phenobarbital; 5-ethyl-5-phenylpyrimidine-2,4,6(1H,3H,5H)-trione; Thenobarbital; 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl-; 5-ethyl-5-phenyl-1,3-diazinane-2,4,6-trione; Dormital; Phenylethylbarbitursaeure; Phenylaethylbarbitursaeure; 5-Ethyl-5-phenyl-2,4,6(1H,3H,5H)-pyrimidinetrione; Barbituric acid, 5-ethyl-5-phenyl-; 5-Ethyl-5-phenyl-pyrimidine-2,4,6-trione; Barbilehae (barbilettae); UNII-YQE403BP4D; component of Tedral; Sedonal (sedative); component of Slowten; CHEBI:8069; component of Antrocol; component of Hecadrol; component of Bronkotabs; 5-Ethyl-5-phenyl-2,4,6-(1H,3H,5H)pyrimidinetrione; component of Primatene P; CHEMBL40; component of Valpin 50-PB; YQE403BP4D; Austrominal; Phenobarbitalum; Phenobarbitonum; NSC-9848; Phenobarbital (in methanol solution); NSC-128143; NCGC00159493-02; Fenobarbitale; Fenobarbitale [DCIT]; Elixir of phenobarbital; Phenobarbitalum [INN]; DSSTox_CID_1122; Chardonna-2; DSSTox_RID_75953; DSSTox_GSID_21122; Phenylethyl barbituric acid; Fenobarbital [INN-Spanish]; Phenyl-ethyl-barbituric acid; Phenobarbitalum [INN-Latin]; WLN: T6VMVMV FHJ F2 FR; Barbinol; Fenemal recip; CAS-50-06-6; Levsin PB Drops and Tablets; 11097-06-6; CCRIS 502; Luminal (TN); phenobarbital (PB); Acido 5-fenil-5-etilbarbiturico; HSDB 3157; Acido 5-fenil-5-etilbarbiturico [Italian]; 5-Ethyl-5-phenyl-2,6(1H,3H,5H)-pyrimidinetrione; EINECS 200-007-0; 2,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl-; NSC 128143; Phenobar; AI3-02726; Phenobarbital [USP:INN:BAN:JAN]; Tedral (Salt/Mix); Primidone Impurity B; Kinesed (Salt/Mix); Antrocol (Salt/Mix); Donnatal (Salt/Mix); Donnazyme (Salt/Mix); Quadrinal (Salt/Mix); Mephobarbital M (nor); Barbidonna (Salt/Mix); Bronkotabs (Salt/Mix); PHENOBARBITAL CIV; Chardonna-2 (Salt/Mix); Epitope ID:116048; BIDD:PXR0061; Oprea1_384816; SCHEMBL16583; 5-ethyl-5-phenyl-hexahydropyrimidine-2,4,6-trione; Methylphenobarbital, M(nor-); MLS001240232; DivK1c_000987; GTPL2804; DTXSID5021122; SCHEMBL11114624; HMS503E15; KBio1_000987; NSC9848; Phenobarbital (JP17/USP/INN); NINDS_000987; HMS2272G06; Tox21_111713; Tox21_200510; BBL028111; BDBM50021437; NSC128143; STL367898; ZINC95588079; component of Primatene P (Salt/Mix); Phenobarbital 0.1 mg/ml in Methanol; Phenobarbital 1.0 mg/ml in Methanol; AKOS000605404; AKOS015964976; Barbituric acid, 5-ethyl-5-phenyl-,; AB02704; DB01174; MCULE-1782264021; component of Valpin 50-PB (Salt/Mix); IDI1_000987; NSC-128143-; Levsin PB Drops and Tablets (Salt/Mix); NCGC00159493-03; NCGC00159493-04; NCGC00258064-01; SMR000058986; DB-051722; C07434; D00506; Phenobarbital solution, 1.0 mg/mL in methanol; A827956; Q407241; SR-01000313151; SR-01000313151-1; Phenobarbital, United States Pharmacopeia (USP) Reference Standard
Clinical Status
Approved
Disease Indication Epilepsy ICD-11: 8A60 [1]
PubChem CID
4763
Formula
C12H12N2O3
Canonical SMILES
CCC1(C(=O)NC(=O)NC1=O)C2=CC=CC=C2
InChI
1S/C12H12N2O3/c1-2-12(8-6-4-3-5-7-8)9(15)13-11(17)14-10(12)16/h3-7H,2H2,1H3,(H2,13,14,15,16,17)
InChIKey
DDBREPKUVSBGFI-UHFFFAOYSA-N
   Click to Show/Hide the Molecular Data (Structure/Property) of This API
Structure
<iframe style="width: 300px; height: 300px;" frameborder="0" src="https://embed.molview.org/v1/?mode=balls&cid=4763"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 232.23 Topological Polar Surface Area 75.3
XlogP 1.5 Complexity 339
Heavy Atom Count 17 Rotatable Bond Count 2
Hydrogen Bond Donor Count 2 Hydrogen Bond Acceptor Count 3
Full List of Drug Formulations (DFMs) Containing This API
          Phenobarbital 100 mg tablet Click to Show/Hide the Full List of Formulation(s):          1 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; Lactose monohydrate; Docusate sodium; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato; Starch, corn
                   Dosage Form Oral Tablet
                   Company C.O. Truxton; West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Docusate sodium DIG Info Solute carrier SLCO2B1 (Ki = 2.3 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 60 mg tablet Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; Lactose monohydrate; Docusate sodium; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato; Starch, corn
                   Dosage Form Oral Tablet
                   Company RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Docusate sodium DIG Info Solute carrier SLCO2B1 (Ki = 2.3 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Calcium stearate; Silicon dioxide; Cellulose, microcrystalline; Starch, corn
                   Dosage Form Oral Tablet
                   Company AvPAK; C.O. Truxton; McKesson; West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 16.2 mg tablet Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company e5 Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Bryant Ranch Prepack; Cardinal Health; ECI Pharmaceuticals; McKesson; Qualitest Pharmaceuticals; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 32.4 mg tablet Click to Show/Hide the Full List of Formulation(s):          3 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company e5 Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company American Health Packaging; Aphena Pharma Solutions-Tennessee; Cardinal Health; Contract Pharmacal; ECI Pharmaceuticals; McKesson; PD-Rx Pharmaceuticals; Qualitest Pharmaceuticals; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Microcrystalline cellulose; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Major Pharmaceuticals; Proficient Rx
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 64.8 mg tablet Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company e5 Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company American Health Packaging; Contract Pharmacal; DirectRX; ECI Pharmaceuticals; Qualitest Pharmaceuticals; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 97.2 mg tablet Click to Show/Hide the Full List of Formulation(s):          3 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Anhydrous lactose; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company e5 Pharma
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; Sodium lauryl sulfate; Magnesium stearate; Cellulose, microcrystalline; Sodium starch glycolate type a corn; Starch, pregelatinized corn
                   Dosage Form Oral Tablet
                   Company Sterling Knight Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [4]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company American Health Packaging; ECI Pharmaceuticals; Qualitest Pharmaceuticals; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Phenobarbital 30 mg tablet Click to Show/Hide the Full List of Formulation(s):          3 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company PD-Rx Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Calcium stearate; Silicon dioxide; Cellulose, microcrystalline; Starch, corn
                   Dosage Form Oral Tablet
                   Company AvPAK; C.O. Truxton; McKesson; West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Calcium stearate; Cellulose, microcrystalline; Colloidal silicon dioxide; Starch, corn
                   Dosage Form Oral Tablet
                   Company UDL Laboratories
          Phenobarbital 15 mg tablet Click to Show/Hide the Full List of Formulation(s):          1 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Calcium stearate; Silicon dioxide; Cellulose, microcrystalline; Starch, corn
                   Dosage Form Oral Tablet
                   Company AvPAK; Bryant Ranch Prepack; C.O. Truxton; McKesson; West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
References
1 FDA label for approved phenobarbital from the official website of the U.S. Food and Drug Administration.
2 The activities of drug inactive ingredients on biological targets. Science. 2020 Jul 24;369(6502):403-413.
3 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
4 Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives. Proc Natl Acad Sci U S A. 2020 Jul 7;117(27):16009-16018.

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