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Hydroxyzine Pamoate

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 7 USDMF, 1 JDMF, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

10 API Suppliers
7 USDMF
1 JDMF
7 NDC API
5 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 41 FDA Orange Book

41 FDF Dossiers
41 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE, CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

drugProductComposition
CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE
CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

RELATED EXCIPIENT COMPANIES

6 DKSH, 4 ACG Worldwide, 1 Gangwal Chemicals, 3 Lonza Capsugel, 1 Qualicaps, 2 Roquette

relatedExcipients
6 DKSH
4 ACG Worldwide
1 Gangwal Chemicals
3 Lonza Capsugel
1 Qualicaps
2 Roquette

EXCIPIENTS BY APPLICATIONS

8 Empty Capsules, 5 Coating Systems & Additives, 4 Fillers, Diluents & Binders, 4 Thickeners and Stabilizers, 2 Film Formers & Plasticizers, 2 Coloring Agents, 1 Taste Masking

excipientsByApplications
8 Empty Capsules
5 Coating Systems & Additives
4 Fillers, Diluents & Binders
4 Thickeners and Stabilizers
2 Film Formers & Plasticizers
2 Coloring Agents
1 Taste Masking

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

globalSalesInformation
2 US Medicaid Prescriptions

MARKET PLACE

3 FDF Dossiers

marketPlace
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 188

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

18,127,362

Annual Reports (USD Million)

Finished Drug Prices

17 RELATED EXCIPIENT COMPANIES

26EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 10246-75-0, Hydroxyzine embonate, Bobsule, Hydroxyzine (pamoate), Equipose, Hydroxyzine pamoate salt

Molecular Formula

C₄₄H₄₃ClN₂O₈

Molecular Weight

763.3 g/mol

InChI Key

ASDOKGIIKXGMNB-UHFFFAOYSA-N

FDA UNII

M20215MUFR

A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

1 2D Structure

Hydroxyzine Pamoate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic acid;2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol

2.1.2 InChI

InChI=1S/C23H16O6.C21H27ClN2O2/c24-20-16(14-7-3-1-5-12(14)9-18(20)22(26)27)11-17-15-8-4-2-6-13(15)10-19(21(17)25)23(28)29;22-20-8-6-19(7-9-20)21(18-4-2-1-3-5-18)24-12-10-23(11-13-24)14-16-26-17-15-25/h1-10,24-25H,11H2,(H,26,27)(H,28,29);1-9,21,25H,10-17H2

2.1.3 InChI Key

ASDOKGIIKXGMNB-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCOCCO)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.C1=CC=C2C(=C1)C=C(C(=C2CC3=C(C(=CC4=CC=CC=C43)C(=O)O)O)O)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

M20215MUFR

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol

2. Atarax

3. Durrax

4. Hydroxyzine

5. Hydroxyzine Dihydrochloride

6. Hydroxyzine Hydrochloride

7. Orgatrax

8. Pamoate, Hydroxyzine

9. Vistaril

2.3.2 Depositor-Supplied Synonyms

1. 10246-75-0

2. Hydroxyzine Embonate

3. Bobsule

4. Hydroxyzine (pamoate)

5. Equipose

6. Hydroxyzine Pamoate Salt

7. Hy-pam

8. Nsc-757063

9. Mls000028605

10. M20215mufr

11. Masmoran

12. Paxisitil

13. Smr000058728

14. Atarax P

15. 4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic Acid;2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol

16. Sr-01000003149

17. Einecs 233-582-1

18. Unii-m20215mufr

19. Hydroxyzine Pamoate [usp:jan]

20. Atarax-p (tn)

21. Spectrum_000911

22. Vistaril Pamoate (tn)

23. Spectrum2_001000

24. Spectrum3_000463

25. Spectrum4_000013

26. Spectrum5_000838

27. Hyydroxyzine Pamoate

28. 6-ethylthiomorpholin-3-one

29. Schembl41333

30. Bspbio_002166

31. Kbiogr_000385

32. Kbioss_001391

33. 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

34. Divk1c_000503

35. Spectrum1500345

36. Spbio_001099

37. Chembl1200467

38. Hydroxyzine Pamoate [mi]

39. Hms501j05

40. Kbio1_000503

41. Kbio2_001391

42. Kbio2_003959

43. Kbio2_006527

44. Kbio3_001386

45. Dtxsid00907580

46. Hydroxyzine Pamoate [jan]

47. Hydroxyzine Pamoate (jp17/usp)

48. Ninds_000503

49. Hms1920f11

50. Hms2091l19

51. Hms2235o19

52. Hms3886g14

53. Pharmakon1600-01500345

54. Hydroxyzine Pamoate [vandf]

55. Hy-b0895

56. Ccg-40218

57. Hydroxyzine Embonate [mart.]

58. Hydroxyzine Pamoate [usp-rs]

59. Mfcd00058051

60. Nsc757063

61. S5649

62. Hydroxyzine Embonate [who-dd]

63. Akos015914218

64. Nsc 757063

65. Idi1_000503

66. Hydroxyzine Pamoate [orange Book]

67. Ncgc00021152-02

68. Ncgc00021152-03

69. Ncgc00094698-01

70. Ncgc00094698-02

71. (+-)-2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

72. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, (+-)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

73. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

74. Hydroxyzine Pamoate [usp Monograph]

75. Sbi-0051413.p003

76. Ft-0697190

77. Hydroxyzine Pamoate Salt, Analytical Standard

78. D01096

79. F15112

80. J-000695

81. Sr-01000003149-2

82. Sr-01000003149-4

83. Q27114645

84. Hydroxyzine Pamoate, United States Pharmacopeia (usp) Reference Standard

85. (+/-)-2-(2-(4-(p-chloro-.alpha.-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

86. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, (+/-)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₄₄H₄₃ClN₂O₈
Molecular Weight	763.3 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	12
Exact Mass	762.2707940 g/mol
Monoisotopic Mass	762.2707940 g/mol
Topological Polar Surface Area	151 Å²
Heavy Atom Count	55
Formal Charge	0
Complexity	945
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Hydroxyzine pamoate
PubMed Health	Hydroxyzine Pamoate (By mouth)
Drug Classes	Antianxiety, Antiemetic, Respiratory Agent
Drug Label	Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1'-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C21H27ClN2O2C23H1...
Active Ingredient	Hydroxyzine pamoate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg hydrochloride; eq 50mg hcl; eq 100mg hcl; eq 25mg hcl; eq 25mg hydrochloride
Market Status	Prescription
Company	Sandoz; Watson Labs; Emcure Pharms Usa; Barr

2 of 2
Drug Name	Hydroxyzine pamoate
PubMed Health	Hydroxyzine Pamoate (By mouth)
Drug Classes	Antianxiety, Antiemetic, Respiratory Agent
Drug Label	Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1'-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C21H27ClN2O2C23H1...
Active Ingredient	Hydroxyzine pamoate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg hydrochloride; eq 50mg hcl; eq 100mg hcl; eq 25mg hcl; eq 25mg hydrochloride
Market Status	Prescription
Company	Sandoz; Watson Labs; Emcure Pharms Usa; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Histamine Receptor Antagonists [MoA]; Antihistamine [EPC]

API SUPPLIERS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Chemi Spa

Italy

Medlab Asia & Asia Health

Not Confirmed

Not Confirmed

05

Ipca Laboratories Ltd

India

Medlab Asia & Asia Health

Not Confirmed

06

Symed Labs Ltd

India

Medlab Asia & Asia Health

Not Confirmed

07

Ucb Pharmaceuticals Inc

Belgium

Medlab Asia & Asia Health

Not Confirmed

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JDMF

01

COSMA S. P. A.

Italy

Medlab Asia & Asia Health

Not Confirmed

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NDC API

01

COSMA Spa

Medlab Asia & Asia Health

Not Confirmed

07

Uquifa Spain

Spain

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

01

COSMA S.p.A

Italy

Medlab Asia & Asia Health

Not Confirmed

02

Fleming Laboratories

India

Spain

Medlab Asia & Asia Health

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

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A.","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"699.00","actualQuantity":"699","unit":"KGS","unitRateFc":"200","totalValueFC":"141403.7","currency":"USD","unitRateINR":"16910","date":"30-Jul-2024","totalValueINR":"11820090","totalValueInUsd":"141403.7","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"4787557","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO(BG) ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"HYDROXYZINE PAMOATE F515\/2024 (BATCH NO. 101424038) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"768.00","actualQuantity":"768","unit":"KGS","unitRateFc":"200","totalValueFC":"155362","currency":"USD","unitRateINR":"16910","date":"30-Jul-2024","totalValueINR":"12986880","totalValueInUsd":"155362","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"4787557","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO(BG) ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"HYDROXYZINE PAMOATE F529\/2024 (BATCH NO. 101424040) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"753.00","actualQuantity":"753","unit":"KGS","unitRateFc":"200","totalValueFC":"152327.6","currency":"USD","unitRateINR":"16910","date":"30-Jul-2024","totalValueINR":"12733230","totalValueInUsd":"152327.6","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"4787557","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO(BG) ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"HYDROXYZINE PAMOATE USP LOT NO:20090614 ( QTY 21.742 KGS)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHRMACEUTICALS OF LLC","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"21.74","actualQuantity":"21.742","unit":"KGS","unitRateFc":"173.5","totalValueFC":"5057.7","currency":"USD","unitRateINR":"19512.1","date":"31-Aug-2024","totalValueINR":"424232.58","totalValueInUsd":"5057.7","indian_port":"Ahmedabad Air","hs_no":"29335990","bill_no":"5348501","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"50 HORSEBLOCK RD BROOKHAVEN NY 11719 USASDNF UNITED STATES","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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FDF Dossiers

01

Actavis Inc

Ireland

Medlab Asia & Asia Health

Not Confirmed

02

Actavis Inc

Medlab Asia & Asia Health

Not Confirmed

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DOSAGE - CAPSULE;ORAL - EQ 100MG HYDROCHLORID...DOSAGE - CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11459

DOSAGE - CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE

USFDA APPLICATION NUMBER - 11459

DOSAGE - CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

USFDA APPLICATION NUMBER - 11459

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

7 USDMF

1 JDMF

7 NDC API

5 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers

41 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE

CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

RELATED EXCIPIENT COMPANIES

6 DKSH

4 ACG Worldwide

1 Gangwal Chemicals

3 Lonza Capsugel

1 Qualicaps

2 Roquette

EXCIPIENTS BY APPLICATIONS

8 Empty Capsules

5 Coating Systems & Additives

4 Fillers, Diluents & Binders

4 Thickeners and Stabilizers

2 Film Formers & Plasticizers

2 Coloring Agents

1 Taste Masking

DIGITAL CONTENT

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

MARKET PLACE

3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 188

MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

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PATENTS & EXCLUSIVITIES

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26EXCIPIENTS BY APPLICATIONS

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CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons