All Manufacturers, Suppliers, Distributors and Exporters of Fexofenadine with approved Medicines Control Council in South Africa of Finished Dosage Form listed on PharmaCompass.com

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Also known as: 153439-40-8, Fexofenadine hcl, Allegra, Telfast, 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride, Mdl 16,455a
Molecular Formula
C32H40ClNO4
Molecular Weight
538.1  g/mol
InChI Key
RRJFVPUCXDGFJB-UHFFFAOYSA-N
FDA UNII
2S068B75ZU

Fexofenadine Hydrochloride
Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine, a carboxylated metabolic derivative of terfenadine and second generation, long-lasting selective histamine H1 receptor antagonist, with antihistaminic activity. Upon administration, fexofenadine competitively binds of peripheral H1-receptors in the gastrointestinal (GI) tract, blood vessels, and bronchial smooth muscle. This prevents binding of histamine to peripheral H1-receptors and prevents their activation. This prevents a histamine-mediated allergic reaction. Fexofenadine does not cross the blood-brain-barrier (BBB).
1 2D Structure

Fexofenadine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid;hydrochloride
2.1.2 InChI
InChI=1S/C32H39NO4.ClH/c1-31(2,30(35)36)25-17-15-24(16-18-25)29(34)14-9-21-33-22-19-28(20-23-33)32(37,26-10-5-3-6-11-26)27-12-7-4-8-13-27;/h3-8,10-13,15-18,28-29,34,37H,9,14,19-23H2,1-2H3,(H,35,36);1H
2.1.3 InChI Key
RRJFVPUCXDGFJB-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C1=CC=C(C=C1)C(CCCN2CCC(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)O)C(=O)O.Cl
2.2 Other Identifiers
2.2.1 UNII
2S068B75ZU
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Allegra

2. Alpha-(4-(1-carboxy-1-methylethyl)phenyl)-4-hydroxydiphenylmethyl-1-piperidinebutanol

3. Fexofenadine

4. Mdl 16,455a

5. Mdl 16.455

6. Mdl 16455

7. Mdl-16455

8. Telfast

2.3.2 Depositor-Supplied Synonyms

1. 153439-40-8

2. Fexofenadine Hcl

3. Allegra

4. Telfast

5. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hydrochloride

6. Mdl 16,455a

7. 138452-21-8

8. Fexofenadine (hydrochloride)

9. Mdl 16455

10. Mdl-16455a

11. Terfenadine Carboxylate Hydrochloride

12. 2s068b75zu

13. Mdl 16455a

14. 2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanoic Acid Hydrochloride

15. 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic Acid;hydrochloride

16. 153439-40-8 (hcl)

17. Dsstox_cid_28642

18. Dsstox_rid_82912

19. Dsstox_gsid_48716

20. Allegra Allergy

21. Allegra Hives

22. Smr000718798

23. Cas-153439-40-8

24. Ncgc00015453-05

25. Children's Allegra Hives

26. Fexofenidine Hydrochloride

27. Children's Allegra Allergy

28. Terfenidine

29. Altiva

30. Unii-2s068b75zu

31. Carboxyterfenadine Hydrochloride

32. Allegra Flash

33. Sr-01000075889

34. Allegra Od

35. Fexofenadine Hydrochloride [usan]

36. Fexofenadine, Hcl

37. Allegra (tn)

38. Terfenidine Carboxylate Hydrochloride

39. Mfcd00865710

40. Fexofenadine Hydrochloride [usan:usp]

41. Fexofenadina Cloridrato

42. Fexofenadine-d10 Hcl

43. Cloridrato De Fexofenadina

44. Clorhidrato De Fexofenadina

45. Chlorhydrate De Fexofenadine

46. Mdl-16455 Hydrochloride

47. Schembl40914

48. Mls001306422

49. Mls001332493

50. Mls001332494

51. Fexofenadine Impurity Standard

52. Spectrum1504179

53. Chebi:5051

54. Chembl1200618

55. Dtxsid5048716

56. Hy-b0801a

57. Fexofenadine Hydrochloride- Bio-x

58. Pharmakon1600-01504179

59. Tox21_113125

60. Nsc758678

61. S3208

62. Akos015907422

63. Tox21_113125_1

64. Ab07499

65. Ccg-213275

66. Cs-4483

67. Fexofenadine Hydrochloride (jp17/usp)

68. Fexofenadine Hydrochloride [mi]

69. Ks-1057

70. Nc00724

71. Nsc 758678

72. Nsc-758678

73. Fexofenadine Hydrochloride [jan]

74. Ncgc00015453-02

75. Ncgc00015453-08

76. Ncgc00092389-01

77. Ncgc00095906-01

78. Ncgc00095906-02

79. (+-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-alpha-methylhydratropic Acid Hydrochloride

80. Ac-24745

81. Bf164454

82. Fexofenadine Hydrochloride [mart.]

83. Fexofenadine Hydrochloride [vandf]

84. Fexofenadine Hydrochloride [usp-rs]

85. Fexofenadine Hydrochloride [who-dd]

86. Fexofenadine Hydrochloride, >98% (hplc)

87. Db-043190

88. A3371

89. F0698

90. Ft-0631183

91. M-016455-o

92. Sw199568-2

93. Bim-0050472.0001

94. D00671

95. Fexofenadine Hydrochloride [orange Book]

96. Fexofenadine Hydrochloride [ep Monograph]

97. Fexofenadine Hydrochloride [usp Impurity]

98. 452f218

99. Fexofenadine Hydrochloride [usp Monograph]

100. J-505843

101. Sr-01000075889-6

102. Allegra-d Component Fexofenadine Hydrochloride

103. Q27255526

104. Fexofenadine Hydrochloride 100 Microg/ml In Acetonitrile

105. Fexofenadine Hydrochloride Component Of Allegra-d

106. Z2210694607

107. Fexofenadine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

108. Fexofenadine Hcl, Pharmaceutical Secondary Standard; Certified Reference Material

109. Fexofenadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

110. (+/-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-.alpha.-methylhydratropic Acid, Hydrochloride

111. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hcl

112. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid

113. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid; Hydrochloride;fexofenadine Hcl

114. 4-[(4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

115. 4-[4-[4-(hydroxydiphenylmethyl)-1-pieridinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

116. 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride

117. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-.alpha.,.alpha.-dimethyl-, Hydrochloride, (+/-)-

118. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride

119. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride, (+-)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 538.1 g/mol
Molecular Formula C32H40ClNO4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count5
Rotatable Bond Count10
Exact Mass537.2645865 g/mol
Monoisotopic Mass537.2645865 g/mol
Topological Polar Surface Area81 Ų
Heavy Atom Count38
Formal Charge0
Complexity678
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAllegra
PubMed HealthFexofenadine/Pseudoephedrine (By mouth)
Drug ClassesAntihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
Drug LabelFexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim...
Active IngredientFexofenadine hydrochloride
Dosage FormSuspension
RouteOral
Strength30mg/5ml
Market StatusPrescription
CompanySanofi Aventis Us

2 of 4  
Drug NameFexofenadine hydrochloride
Drug LabelFexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry...
Active IngredientFexofenadine hydrochloride
Dosage FormTablet; Suspension
Routeoral; Oral
Strength180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
Market StatusTentative Approval; Prescription
CompanyRanbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr

3 of 4  
Drug NameAllegra
PubMed HealthFexofenadine/Pseudoephedrine (By mouth)
Drug ClassesAntihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination
Drug LabelFexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim...
Active IngredientFexofenadine hydrochloride
Dosage FormSuspension
RouteOral
Strength30mg/5ml
Market StatusPrescription
CompanySanofi Aventis Us

4 of 4  
Drug NameFexofenadine hydrochloride
Drug LabelFexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry...
Active IngredientFexofenadine hydrochloride
Dosage FormTablet; Suspension
Routeoral; Oral
Strength180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml
Market StatusTentative Approval; Prescription
CompanyRanbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Allergic Agents

Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)


Histamine H1 Antagonists, Non-Sedating

A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

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FEXON0U003)","address":"B\/2 MAHALAXMI CHAMBERS22 BHULABHAI DESAI ROAD","city":"MUMBAI. MAHARASHTRA","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"300","totalValueFC":"1214.1","currency":"USD","unitRateINR":"22620","date":"26-Jul-2021","totalValueINR":"90480","totalValueInUsd":"1214.1","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"4821548","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS22 BHULABHAI DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686853800,"product":"FEXOFENADINE RELATED COMPOUND C (QTY:1 X 0.2 GMS, VALUE: USD54.70) (FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"273500","totalValueFC":"58.1","currency":"USD","unitRateINR":"23895349.7","date":"16-Jun-2023","totalValueINR":"4778.921","totalValueInUsd":"58.1","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691692200,"product":"FEXOFENADINE HYDROCHLORIDE REIMPORT AFTER REJECTION","address":"SCO.850, SHIVALIK ENCLAVE, NAC,,MA NIMAJRA, ,","city":"CHANDIGARH","supplier":"SUMITOMO CORPORATION","supplierCountry":"INDIA","foreign_port":"NA","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"273","totalValueFC":"11494.6","currency":"USD","unitRateINR":"23650.4","date":"11-Aug-2023","totalValueINR":"955571.408","totalValueInUsd":"11494.6","indian_port":"DELHI AIR","hs_no":"29333200","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SCO.850, SHIVALIK ENCLAVE, NAC,,MA NIMAJRA, ,"}]
02-Jan-2021
30-Aug-2024
KGS
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Average Price (USD/KGS)

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
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Average Price
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SUSPENSION;ORAL - 30MG/5ML

USFDA APPLICATION NUMBER - 201373

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

USFDA APPLICATION NUMBER - 20786

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DOSAGE - TABLET;ORAL - 180MG

USFDA APPLICATION NUMBER - 20872

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DOSAGE - TABLET;ORAL - 30MG **Federal Registe...DOSAGE - TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20872

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DOSAGE - TABLET;ORAL - 60MG

USFDA APPLICATION NUMBER - 20872

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

USFDA APPLICATION NUMBER - 21704

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG

USFDA APPLICATION NUMBER - 21909

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DOSAGE - SUSPENSION;ORAL - 30MG/5ML

USFDA APPLICATION NUMBER - 21963

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