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Chemistry

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Also known as: 140462-76-6, Olopatadine hcl, Allelock, Pataday, Patanase, Alo4943a
Molecular Formula
C21H24ClNO3
Molecular Weight
373.9  g/mol
InChI Key
HVRLZEKDTUEKQH-NOILCQHBSA-N
FDA UNII
2XG66W44KF

Olopatadine Hydrochloride
An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS.
1 2D Structure

Olopatadine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid;hydrochloride
2.1.2 InChI
InChI=1S/C21H23NO3.ClH/c1-22(2)11-5-8-18-17-7-4-3-6-16(17)14-25-20-10-9-15(12-19(18)20)13-21(23)24;/h3-4,6-10,12H,5,11,13-14H2,1-2H3,(H,23,24);1H/b18-8-;
2.1.3 InChI Key
HVRLZEKDTUEKQH-NOILCQHBSA-N
2.1.4 Canonical SMILES
CN(C)CCC=C1C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O.Cl
2.1.5 Isomeric SMILES
CN(C)CC/C=C\1/C2=CC=CC=C2COC3=C1C=C(C=C3)CC(=O)O.Cl
2.2 Other Identifiers
2.2.1 UNII
2XG66W44KF
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid

2. 4679, Kw

3. Hydrochloride, Olopatadine

4. Kw 4679

5. Kw 4943a

6. Kw-4679

7. Kw-4943a

8. Kw4943a

9. Olopatadine

10. Patanol

2.3.2 Depositor-Supplied Synonyms

1. 140462-76-6

2. Olopatadine Hcl

3. Allelock

4. Pataday

5. Patanase

6. Alo4943a

7. Pazeo

8. Kw4679

9. Kw-4679

10. Olopatadine (hydrochloride)

11. Alo-4943a

12. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic Acid Hydrochloride

13. Olopatadine (as Hydrochloride)

14. 2xg66w44kf

15. Dsstox_cid_26486

16. Dsstox_rid_81657

17. Dsstox_gsid_46486

18. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-

19. Olopine

20. Patadine

21. Olopax

22. Chembl1719

23. Kw 4679

24. Cas-140462-76-6

25. Opatanol (tn)

26. Unii-2xg66w44kf

27. Sr-01000763388

28. Alo 4943a

29. Olopatadine Hydrochloride [usan]

30. Allelock (tn)

31. Patanol (tn)

32. De 114

33. Mfcd00875716

34. Olopatadine Hydrochloride [usan:usp]

35. Olopatadine Hydrochlorde

36. O-ppds

37. Ncgc00164623-01

38. Schembl23213

39. Mls001401465

40. Dtxsid0046486

41. Chebi:31933

42. Hy-b0426a

43. Olopatadine Hydrochloride- Bio-x

44. Al4943a

45. Alo4943a;kw4679

46. 2-[(11z)-11-[3-(dimethylamino)propylidene]-6h-benzo[c][1]benzoxepin-2-yl]acetic Acid;hydrochloride

47. Dibenz[b,e]oxepin-2-acetic Acid, 11-[3-(dimethylamino)propylidene]-6,11-dihydro-, Hydrochloride (1:1), (11z)-

48. Ex-a1347

49. Olopatadine Hydrochloride (opatanol)

50. Tox21_112242

51. S2494

52. Olopatadine Hydrochloride [mi]

53. Akos015895232

54. Akos025149118

55. Olopatadine Hydrochloride (jp17/usp)

56. Tox21_112242_1

57. Bcp9001022

58. Ccg-101141

59. H06o056

60. Ks-1228

61. Nc00391

62. Olopatadine Hydrochloride [jan]

63. Ncgc00263532-01

64. Olopatadine Hydrochloride [mart.]

65. Olopatadine Hydrochloride [vandf]

66. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid Hydrochloride

67. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid, Hydrochloride

68. Bo164171

69. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-

70. Olopatadine Hydrochloride [usp-rs]

71. Olopatadine Hydrochloride [who-dd]

72. Smr000469220

73. Olopatadine Hydrochloride, >=98% (hplc)

74. Olopatadine Hydrochloride [ema Epar]

75. O0361

76. C72607

77. D01192

78. Olopatadine Hydrochloride [orange Book]

79. Olopatadine Hydrochloride [usp Monograph]

80. A807652

81. Ryaltris Component Olopatadine Hydrochloride

82. Q-201511

83. Sr-01000763388-4

84. Olopatadine Hydrochloride Component Of Ryaltris

85. Q27255766

86. Olopatadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

87. (z)-11-[3-(dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic Acid Hydrochloride

88. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)aceticacidhydrochloride

2.4 Create Date
2005-10-11
3 Chemical and Physical Properties
Molecular Weight 373.9 g/mol
Molecular Formula C21H24ClNO3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass373.1444713 g/mol
Monoisotopic Mass373.1444713 g/mol
Topological Polar Surface Area49.8 Ų
Heavy Atom Count26
Formal Charge0
Complexity488
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameOlopatadine hydrochloride
Drug LabelOlopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops; Spray, metered; Solution
RouteOphthalmic; Nasal; ophthalmic
Strength0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2%
Market StatusTentative Approval; Prescription
CompanyWockhardt; Apotex; Sandoz; Watson Labs; Barr

2 of 8  
Drug NamePataday
Drug LabelPATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.2% base
Market StatusPrescription
CompanyAlcon Pharms

3 of 8  
Drug NamePatanase
PubMed HealthOlopatadine (Into the nose)
Drug ClassesNasal Agent
Drug LabelPATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T...
Active IngredientOlopatadine hydrochloride
Dosage FormSpray, metered
RouteNasal
Strength0.665mg/spray
Market StatusPrescription
CompanyAlcon Pharms

4 of 8  
Drug NamePatanol
PubMed HealthOlopatadine
Drug ClassesNasal Agent, Ophthalmologic Agent
Drug LabelPATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.1% base
Market StatusPrescription
CompanyAlcon

5 of 8  
Drug NameOlopatadine hydrochloride
Drug LabelOlopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops; Spray, metered; Solution
RouteOphthalmic; Nasal; ophthalmic
Strength0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2%
Market StatusTentative Approval; Prescription
CompanyWockhardt; Apotex; Sandoz; Watson Labs; Barr

6 of 8  
Drug NamePataday
Drug LabelPATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.2% base
Market StatusPrescription
CompanyAlcon Pharms

7 of 8  
Drug NamePatanase
PubMed HealthOlopatadine (Into the nose)
Drug ClassesNasal Agent
Drug LabelPATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T...
Active IngredientOlopatadine hydrochloride
Dosage FormSpray, metered
RouteNasal
Strength0.665mg/spray
Market StatusPrescription
CompanyAlcon Pharms

8 of 8  
Drug NamePatanol
PubMed HealthOlopatadine
Drug ClassesNasal Agent, Ophthalmologic Agent
Drug LabelPATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to...
Active IngredientOlopatadine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.1% base
Market StatusPrescription
CompanyAlcon

4.2 Drug Indication

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)


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.)


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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Histamine-1 Receptor Inhibitor [EPC]; Mast Cell Stabilizer [EPC]; Decreased Histamine Release [PE]
5.3 ATC Code

S01GX09


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06-Jan-2022
31-May-2025
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE

USFDA APPLICATION NUMBER - 206276

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE

USFDA APPLICATION NUMBER - 20688

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

USFDA APPLICATION NUMBER - 21545

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DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21861

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ABOUT THIS PAGE

Looking for 140462-76-6 / Olopatadine Hydrochloride API manufacturers, exporters & distributors?

Olopatadine Hydrochloride manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Olopatadine Hydrochloride API Price utilized in the formulation of products. Olopatadine Hydrochloride API Price is not always fixed or binding as the Olopatadine Hydrochloride Price is obtained through a variety of data sources. The Olopatadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Olopatadine Hydrochloride

Synonyms

140462-76-6, Olopatadine hcl, Allelock, Pataday, Patanase, Alo4943a

Cas Number

140462-76-6

Unique Ingredient Identifier (UNII)

2XG66W44KF

About Olopatadine Hydrochloride

An antihistamine with mast-cell stabilizing properties used as eye drops in the treatment of ALLERGIC CONJUNCTIVITIS.

PAZEO Manufacturers

A PAZEO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PAZEO, including repackagers and relabelers. The FDA regulates PAZEO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PAZEO 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 PAZEO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

PAZEO Suppliers

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

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

PAZEO USDMF

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

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

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

PAZEO JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The PAZEO Drug Master File in Japan (PAZEO JDMF) empowers PAZEO API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the PAZEO JDMF during the approval evaluation for pharmaceutical products. At the time of PAZEO JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of PAZEO suppliers with JDMF on PharmaCompass.

PAZEO KDMF

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

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

After submitting a PAZEO 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 PAZEO API can apply through the Korea Drug Master File (KDMF).

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

PAZEO WC

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

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

PAZEO 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 PAZEO as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for PAZEO 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 PAZEO 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 PAZEO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PAZEO NDC to their finished compounded human drug products, they may choose to do so.

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

PAZEO GMP

PAZEO 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 PAZEO 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 PAZEO GMP manufacturer or PAZEO GMP API supplier for your needs.

PAZEO CoA

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

PAZEO CoA mostly includes findings from lab analyses of a specific batch. For each PAZEO 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.

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