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Also known as: 122883-93-6, Ziprasidone hcl, Geodon, Zeldox, 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one hydrochloride, Ziprasidone (hydrochloride)
Molecular Formula
C21H22Cl2N4OS
Molecular Weight
449.4  g/mol
InChI Key
NZDBKBRIBJLNNT-UHFFFAOYSA-N
FDA UNII
JAL53626GG

Ziprasidone Hydrochloride
Ziprasidone Hydrochloride is the hydrochloride salt form of ziprasidone, a benzothiazolylpiperazine derivative and an atypical antipsychotic agent with an antischizophrenic property. Ziprasidone hydrochloride functions as an antagonist at the dopamine D2 and serotonin 5-HT2A and 5-HT1D receptors, and as an agonist at the 5-HT1A receptor. Ziprasidone hydrochloride also inhibits synaptic reuptake of serotonin and norepinephrine. The mechanism of action by which ziprasidone hydrochloride exerts its antischizophrenic effect is unknown but is potentially mediated through a combination of dopamine D2 and serotonin 5-HT2 antagonism. This agent also has antagonistic activity against histamine H1 and alpha-1-adrenergic receptors.
1 2D Structure

Ziprasidone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrochloride
2.1.2 InChI
InChI=1S/C21H21ClN4OS.ClH/c22-17-13-18-15(12-20(27)23-18)11-14(17)5-6-25-7-9-26(10-8-25)21-16-3-1-2-4-19(16)28-24-21;/h1-4,11,13H,5-10,12H2,(H,23,27);1H
2.1.3 InChI Key
NZDBKBRIBJLNNT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CN(CCN1CCC2=C(C=C3C(=C2)CC(=O)N3)Cl)C4=NSC5=CC=CC=C54.Cl
2.2 Other Identifiers
2.2.1 UNII
JAL53626GG
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 5-(2-(4-(3-benzisothiazolyl)piperazinyl)ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one

2. Cp 88059

3. Cp 88059-01

4. Cp-88,059

5. Cp-88,059-01

6. Cp-88,059-1

7. Geodon

8. Ziprasidone

9. Ziprasidone Hydrochloride, Monohydrate

10. Ziprazidone

2.3.2 Depositor-Supplied Synonyms

1. 122883-93-6

2. Ziprasidone Hcl

3. Geodon

4. Zeldox

5. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one Hydrochloride

6. Ziprasidone (hydrochloride)

7. 5-[2-[4-(1,2-benzisothiazol-3yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one Hydrochloride

8. Ziprasidone Hydrochloride [usan]

9. Jal53626gg

10. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one Hydrochloride

11. 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one Hydrochloride

12. Cp 88059 (hydrochloride Monohydrate)

13. 122883-93-6 (hcl)

14. 2h-indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, Monohydrochloride

15. 5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-2,3-dihydro-1h-indol-2-one Hydrochloride

16. Cp 88059

17. Ziprasidone Hydrochloride Hydrate

18. C21h21cln4os.hcl

19. Unii-jal53626gg

20. Ziprasidone, Hcl

21. 2h-indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, Hydrochloride (1:1)

22. 2h-indol-2-one, 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-, Hydrochloride (1:1)

23. Cp-88059 Hydrochloride

24. Chembl1712

25. Mls006010221

26. Schembl122876

27. Dtxsid00153762

28. Hy-14542a

29. S1444

30. Akos015848366

31. Ac-7053

32. Ccg-220561

33. Cs-1887

34. Ks-1219

35. 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrochloride

36. Ac-26998

37. Smr002204092

38. Ziprasidone Hydrochloride Anhydrous

39. Sw199027-2

40. Z0032

41. Ziprasidone Hydrochloride Anhydrous [mi]

42. 939z277

43. A890906

44. Sr-01000759387

45. Sr-01000759387-2

46. Ziprasidone Hydrochloride Anhydrous [who-dd]

47. Q27281411

48. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one Hcl

49. 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-2-indolinone Monohydrochloride

50. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)-ethyl)-6-chloroindolin-2-one Hydrochloride

51. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1 -piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol- 2-one Hydrochloride

52. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1, 3-dihydro-2h-indol-2-one Hydrochloride

53. Ziprasidone Hydrochloride Solution, 1.0 Mg/ml In Methanol, Certified Reference Material, Ampule Of 1 Ml

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 449.4 g/mol
Molecular Formula C21H22Cl2N4OS
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count4
Exact Mass448.0891379 g/mol
Monoisotopic Mass448.0891379 g/mol
Topological Polar Surface Area76.7 Ų
Heavy Atom Count29
Formal Charge0
Complexity573
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameZiprasidone hydrochloride
Drug LabelGEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophen...
Active IngredientZiprasidone hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 20mg base; eq 40mg base; eq 80mg base; eq 60mg base
Market StatusPrescription
CompanyMylan Pharms; Wockhardt; Apotex; Lupin Pharms; Sandoz; Dr Reddys Labs

2 of 2  
Drug NameZiprasidone hydrochloride
Drug LabelGEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophen...
Active IngredientZiprasidone hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 20mg base; eq 40mg base; eq 80mg base; eq 60mg base
Market StatusPrescription
CompanyMylan Pharms; Wockhardt; Apotex; Lupin Pharms; Sandoz; Dr Reddys Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antipsychotic Agents

Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)


Serotonin Antagonists

Drugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or SEROTONIN RECEPTOR AGONISTS. (See all compounds classified as Serotonin Antagonists.)


Dopamine Antagonists

Drugs that bind to but do not activate DOPAMINE RECEPTORS, thereby blocking the actions of dopamine or exogenous agonists. Many drugs used in the treatment of psychotic disorders (ANTIPSYCHOTIC AGENTS) are dopamine antagonists, although their therapeutic effects may be due to long-term adjustments of the brain rather than to the acute effects of blocking dopamine receptors. Dopamine antagonists have been used for several other clinical purposes including as ANTIEMETICS, in the treatment of Tourette syndrome, and for hiccup. Dopamine receptor blockade is associated with NEUROLEPTIC MALIGNANT SYNDROME. (See all compounds classified as Dopamine Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Atypical Antipsychotic [EPC]

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30-Jan-2021
30-Sep-2024
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DOSAGE - CAPSULE;ORAL - EQ 80MG BASE

USFDA APPLICATION NUMBER - 20825

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ABOUT THIS PAGE

Ziprasidone Hydrochloride Manufacturers

A Ziprasidone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ziprasidone Hydrochloride, including repackagers and relabelers. The FDA regulates Ziprasidone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ziprasidone Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Ziprasidone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ziprasidone Hydrochloride Suppliers

A Ziprasidone Hydrochloride supplier is an individual or a company that provides Ziprasidone Hydrochloride active pharmaceutical ingredient (API) or Ziprasidone Hydrochloride finished formulations upon request. The Ziprasidone Hydrochloride suppliers may include Ziprasidone Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Ziprasidone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ziprasidone Hydrochloride USDMF

A Ziprasidone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ziprasidone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ziprasidone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ziprasidone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ziprasidone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ziprasidone Hydrochloride USDMF includes data on Ziprasidone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ziprasidone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ziprasidone Hydrochloride suppliers with USDMF on PharmaCompass.

Ziprasidone Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Ziprasidone Hydrochloride Drug Master File in Korea (Ziprasidone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ziprasidone Hydrochloride. The MFDS reviews the Ziprasidone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ziprasidone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Ziprasidone Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ziprasidone Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ziprasidone Hydrochloride suppliers with KDMF on PharmaCompass.

Ziprasidone Hydrochloride CEP

A Ziprasidone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ziprasidone Hydrochloride Certificate of Suitability (COS). The purpose of a Ziprasidone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ziprasidone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ziprasidone Hydrochloride to their clients by showing that a Ziprasidone Hydrochloride CEP has been issued for it. The manufacturer submits a Ziprasidone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ziprasidone Hydrochloride CEP holder for the record. Additionally, the data presented in the Ziprasidone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ziprasidone Hydrochloride DMF.

A Ziprasidone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ziprasidone Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Ziprasidone Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Ziprasidone Hydrochloride WC

A Ziprasidone Hydrochloride written confirmation (Ziprasidone Hydrochloride WC) is an official document issued by a regulatory agency to a Ziprasidone Hydrochloride manufacturer, verifying that the manufacturing facility of a Ziprasidone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ziprasidone Hydrochloride APIs or Ziprasidone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ziprasidone Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Ziprasidone Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Ziprasidone Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ziprasidone Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ziprasidone Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Ziprasidone Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ziprasidone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ziprasidone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ziprasidone Hydrochloride suppliers with NDC on PharmaCompass.

Ziprasidone Hydrochloride GMP

Ziprasidone Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ziprasidone Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ziprasidone Hydrochloride GMP manufacturer or Ziprasidone Hydrochloride GMP API supplier for your needs.

Ziprasidone Hydrochloride CoA

A Ziprasidone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ziprasidone Hydrochloride's compliance with Ziprasidone Hydrochloride specifications and serves as a tool for batch-level quality control.

Ziprasidone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ziprasidone Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ziprasidone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ziprasidone Hydrochloride EP), Ziprasidone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ziprasidone Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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