Details of the Drug Formulations

General Information of Drug (ID: DMCR1MV)

• Drug Name: Itraconazole Drug Info
• Synonyms: Canadiol; Hyphanox; ITCZ; ITZ; Intraconazole; Itraconazol; Itraconazolum; Itrizole; Oriconazole; Orungal; Prokanazol; Sempera; Spherazole; Sporal; Sporanos; Sporanox; Sporonox; Triasporn; Itraconazol [Spanish]; Itraconazole oral solution; Itraconazolum [Latin]; R 51211; Cis-Itraconazole; Itraconazole & Bovine Lactoferrin; Itraconazole & Nyotran; Itrizole (TN); R-51211; Sporanox (TN); Itraconazole & Nyotran(Liposomal Nystatin); Itraconazole (JAN/USAN); Oriconazole, R51211, Sporanox; Itraconazole [USAN:BAN:INN:JAN]; (+-)-1-sec-Butyl-4-(p-(4-(p-(((2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-1-piperazinyl)phenyl)-delta(sup 2)-1,2,4-triazolin-5-one; (1)-cis-4-(4-(4-(4-((2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2,4-dihydro-2-sec-butyl-3H-1,2,4-triazol-3-one; 2-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2,4-dihydro-3H-1,2,4-triazol-3-one; 2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one; 2-butan-2-yl-4-[4-[4-[4-[[(2S,4R)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one; 2-butan-2-yl-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one; 3H-1,2,4-Triazol-3-one, 4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-pipera-zinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl); 4-(4-{4-[4-({[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl}oxy)phenyl]piperazin-1-yl}phenyl)-2-(1-methylpropyl)-2,4-dihydro-3H-1,2,4-triazol-3-one

Indication

Disease Entry	ICD 11	Status	REF
Aspergillosis	1F20	Approved	[1]
Blastomycosis	1F22	Approved	[1]
Fungal infection	1F29-1F2F	Approved	[2]
Fusariosis		Approved	[1]
Histoplasmosis		Approved	[1]
Invasive candidiasis	1F23	Approved	[1]
Mycoses	1F2Z	Approved	[1]
Candidemia	1F23.3Y	Investigative	[1]
Esophageal candidiasis		Investigative	[1]

• Therapeutic Class: Antifungal Agents
• Cross-matching ID:
  PubChem CID: 55283
  ChEBI ID: CHEBI:6076
  CAS Number: 84625-61-6
  TTD ID: D0V4IB
  VARIDT ID: DR00687
  INTEDE ID: DR0895
  ACDINA ID: D00337

Full List of Drug Formulations Containing This Drug

Itraconazole 100 mg capsule

Company	Formulation ID	FDA Description
NorthStar Rx	F10904	Sodium lauryl sulfate; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Isopropyl alcohol; Ammonia; Potassium hydroxide; Propylene glycol; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Poloxamer 188; Polyethylene glycol 20000; Silicon dioxide; Alcohol; Gelatin; Hypromellose 2910 (5 mpa.s); Methylene chloride; Shellac; Starch, corn
Ascend Laboratories	F10905	Sodium lauryl sulfate; Fd&c red no. 40; Butyl alcohol; Fd&c blue no. 1; Isopropyl alcohol; Ammonia; Potassium hydroxide; Propylene glycol; Sucrose; Talc; Titanium dioxide; Fd&c red no. 3; Poloxamer 188; Polyethylene glycol 20000; Silicon dioxide; Alcohol; Gelatin; Hypromellose 2910 (5 mpa.s); Methylene chloride; Shellac
Eon Labs	F10903	D&c yellow no. 10; Fd&c red no. 40; Fd&c blue no. 1; Fd&c blue no. 2; Ferrosoferric oxide; Propylene glycol; Sucrose; Titanium dioxide; Gelatin; Hypromelloses; Polyethylene glycols; Shellac; Starch, corn
Accord Healthcare	F10900	D&c red no. 28; Fd&c blue no. 1; Fd&c blue no. 2; Sucrose; Talc; Titanium dioxide; Polyethylene glycol 20000; Gelatin; Hypromellose 2910 (5 mpa.s); Starch, corn
Alembic Pharmaceuticals	F10906	D&c red no. 22; D&c red no. 28; Fd&c blue no. 1; Sucrose; Titanium dioxide; Polyethylene glycol 20000; Gelatin; Hypromelloses; Starch, corn
Bryant Ranch Prepack	F10907	D&c red no. 22; D&c red no. 28; Fd&c blue no. 1; Fd&c blue no. 2; Sucrose; Titanium dioxide; Gelatin; Hypromelloses; Polyethylene glycols; Starch, corn
Janssen Pharmaceutical	F10908	D&c red no. 22; D&c red no. 28; Fd&c blue no. 1; Fd&c blue no. 2; Sucrose; Titanium dioxide; Gelatin, unspecified; Hypromellose, unspecified; Polyethylene glycol, unspecified; Starch, corn
Amneal Pharmaceuticals	F10897	Sodium lauryl sulfate; Fd&c blue no. 1; Ammonia; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sucrose; Titanium dioxide; Cellulose, microcrystalline; Dextrose; Gelatin; Hypromelloses; Polyethylene glycols; Shellac; Starch, corn
American Health Packaging	F10898	Sodium lauryl sulfate; Fd&c blue no. 1; Ammonia; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sucrose; Titanium dioxide; Dextrose, unspecified form; Gelatin, unspecified; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Shellac; Starch, corn
Jubilant Cadista Pharmaceuticals	F10902	Fd&c blue no. 1; Fd&c blue no. 2; Sucrose; Titanium dioxide; Polyethylene glycol 20000; Gelatin; Hypromelloses; Starch, corn
Mylan Pharamceuticals	F10899	Fd&c blue no. 2; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Sodium hydroxide; Sucrose; Talc; Titanium dioxide; Gelatin, unspecified; Hypromellose, unspecified; Polyethylene glycol, unspecified; Povidone, unspecified; Shellac; Starch, corn
Par Pharmaceutical	F10901	Ferrosoferric oxide; Propylene glycol; Sucrose; Titanium dioxide; Polyethylene glycol 20000; Gelatin; Hypromellose 2910 (5 mpa.s); Shellac; Starch, corn

Itraconazole 200 mg tablet

Company	Formulation ID	FDA Description
Merz Pharmaceuticals	F10909	Lactose; Magnesium stearate; Propylene glycol; Talc; Titanium dioxide; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses

References

• [1] Itraconazole FDA Label
• [2] FDA Approved Drug Products from FDA Official Website. 2009. Application Number: (ANDA) 076104.