Details of the Drug Formulations

General Information of Drug (ID: DMFC71L)

• Drug Name: Clozapine Drug Info
• Synonyms: Asaleptin; CLOZARIL; Clorazil; Clozapin; Clozapina; Clozapinum; Fazaclo; Iprox; Leponex; Lepotex; Fazaclo ODT; C 6305; HF1854; Clopine (TN); Clozapina [INN-Spanish]; Clozapine(tautomer); Clozapinum [INN-Latin]; Clozaril (TN); Denzapine (TN); Fazaclo (TN); Froidir (TN); HF-1854; KS-1166; Klozapol (TN); LEX-123; LX 100-129; Leponex (TN); W-801; Zaponex (TN); Clozapine [USAN:INN:BAN]; Clozapine (JAN/USP/INN); 3-chloro-6-(4-methylpiperazin-1-yl)-5H-benzo[b][1,4]benzodiazepine; 8-Chloro-11-(4-methyl)-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo (b,e)(1,4)diazepine; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo(b,e)(1,4)diazepine; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]-diazepine; 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine; 8-chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine

Indication

Disease Entry	ICD 11	Status	REF
Schizophrenia	6A20	Approved	[1]
Treatment-refractory schizophrenia		Investigative	[2]

• Therapeutic Class: Antipsychotic Agents
• Cross-matching ID:
  PubChem CID: 135398737
  ChEBI ID: CHEBI:3766
  CAS Number: 5786-21-0
  TTD ID: D0Z1RV
  VARIDT ID: DR00474
  INTEDE ID: DR0363
  ACDINA ID: D00145

Full List of Drug Formulations Containing This Drug

Clozapine 100 mg tablet

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F04830	Sodium stearyl fumarate; Aspartame; Fd&c yellow no. 6; Magnesium stearate; Mannitol; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Peppermint
Mylan Pharamceuticals	F04831	Sodium stearyl fumarate; Aspartame; Fd&c yellow no. 6; Magnesium stearate; Mannitol; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose; Peppermint
Teva Pharmaceuticals	F04832	Sodium stearyl fumarate; Aspartame; Magnesium stearate; Mannitol; Xylitol; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose; Peppermint
Mylan Pharamceuticals	F04835	Lactose monohydrate; Sodium lauryl sulfate; Fd&c blue no. 2; Magnesium stearate; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose
Mylan Pharamceuticals	F04844	Lactose monohydrate; Sodium lauryl sulfate; Fd&c blue no. 2; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%)
Teva Pharmaceuticals	F04833	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Microcrystalline cellulose; Mint
Jazz Pharmaceuticals	F04834	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Mint
Accord Healthcare	F04836	Lactose; Magnesium stearate; Talc; Povidone; Silicon dioxide; Mineral oil; Sodium starch glycolate type a potato; Starch, corn
Cardinal Health	F04845	Lactose; Magnesium stearate; Talc; Povidone; Silicon dioxide; Starch, corn
Aurobindo Pharma	F04842	Lactose monohydrate; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Starch, corn
HLS Therapeutics; Novartis Pharmaceuticals Corporation; Sandoz	F04837	Lactose; Magnesium stearate; Talc; Silicon dioxide; Povidones; Starch, corn
American Health Packaging; Avera McKennan Hospital	F04838	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidones; Starch, corn
Avera McKennan Hospital; Teva Pharmaceuticals	F04839	Lactose monohydrate; Magnesium stearate; Talc; Silicon dioxide; Povidone k90; Starch, corn
Actavis Pharma	F04840	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidones; Sodium starch glycolate type a potato; Starch, corn
Sun Pharmaceutical Industries	F04841	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Starch, corn
Mayne Pharma	F04843	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Sodium starch glycolate type a potato; Starch, corn
Cardinal Health	F04846	Lactose monohydrate; Magnesium stearate; Talc; Silicon dioxide; Povidones; Starch, corn

Clozapine 25 mg tablet

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F04859	Sodium stearyl fumarate; Aspartame; Fd&c yellow no. 6; Magnesium stearate; Mannitol; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Peppermint
Mylan Pharamceuticals	F04860	Sodium stearyl fumarate; Aspartame; Fd&c yellow no. 6; Magnesium stearate; Mannitol; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose; Peppermint
Teva Pharmaceuticals	F04861	Sodium stearyl fumarate; Aspartame; Magnesium stearate; Mannitol; Xylitol; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose; Peppermint
Mylan Pharamceuticals	F04872	Lactose monohydrate; Sodium lauryl sulfate; Fd&c red no. 40; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%)
Mylan Pharamceuticals	F04873	Lactose monohydrate; Sodium lauryl sulfate; Fd&c red no. 40; Magnesium stearate; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose
Teva Pharmaceuticals	F04862	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Microcrystalline cellulose; Mint
Jazz Pharmaceuticals	F04863	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Mint
Accord Healthcare	F04864	Lactose; Magnesium stearate; Talc; Povidone; Silicon dioxide; Mineral oil; Sodium starch glycolate type a potato; Starch, corn
Aurobindo Pharma	F04870	Lactose monohydrate; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Starch, corn
HLS Therapeutics; Novartis Pharmaceuticals Corporation; Sandoz; TYA Pharmaceuticals	F04865	Lactose; Magnesium stearate; Talc; Silicon dioxide; Povidones; Starch, corn
American Health Packaging	F04866	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidones; Starch, corn
Teva Pharmaceuticals	F04867	Lactose monohydrate; Magnesium stearate; Talc; Silicon dioxide; Povidone k90; Starch, corn
Actavis Pharma	F04868	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidones; Sodium starch glycolate type a potato; Starch, corn
Sun Pharmaceutical Industries	F04869	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Starch, corn
Mayne Pharma	F04871	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Sodium starch glycolate type a potato; Starch, corn

Clozapine 200 mg tablet

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F04853	Lactose monohydrate; Sodium lauryl sulfate; Fd&c blue no. 2; Magnesium stearate; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Microcrystalline cellulose
Mylan Pharamceuticals	F04857	Lactose monohydrate; Sodium lauryl sulfate; Fd&c blue no. 2; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%)
Jazz Pharmaceuticals	F04852	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Mint
Teva Pharmaceuticals	F04851	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Microcrystalline cellulose; Mint
Aurobindo Pharma	F04855	Lactose monohydrate; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Starch, corn
Teva Pharmaceuticals	F04858	Anhydrous lactose; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Starch, corn
Sun Pharmaceutical Industries	F04854	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Starch, corn
Mayne Pharma	F04856	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Sodium starch glycolate type a potato; Starch, corn

Clozapine 50 mg tablet

Company	Formulation ID	FDA Description
Mylan Pharamceuticals	F04877	Lactose monohydrate; Sodium lauryl sulfate; Fd&c blue no. 2; Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%)
Aurobindo Pharma	F04875	Lactose monohydrate; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Starch, corn
Teva Pharmaceuticals	F04878	Anhydrous lactose; Magnesium stearate; Talc; Povidone k30; Silicon dioxide; Crospovidone (15 mpa.s at 5%); Starch, corn
Sun Pharmaceutical Industries	F04874	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Starch, corn
Mayne Pharma	F04876	Lactose, unspecified form; Magnesium stearate; Talc; Silicon dioxide; Povidone, unspecified; Sodium starch glycolate type a potato; Starch, corn

Clozapine 150 mg tablet

Company	Formulation ID	FDA Description
Jazz Pharmaceuticals	F04850	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Silicon dioxide; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Mint
Teva Pharmaceuticals	F04849	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Microcrystalline cellulose; Mint

Clozapine 12.5 mg tablet

Company	Formulation ID	FDA Description
Teva Pharmaceuticals	F04847	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Microcrystalline cellulose; Mint
Jazz Pharmaceuticals	F04848	Magnesium stearate; Mannitol; Citric acid monohydrate; Ferric oxide yellow; Sodium bicarbonate; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer; Mint

References

• [1] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 38).
• [2] Clozapine FDA Label