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    Chemistry

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    Also known as: 15307-81-0, Cataflam, Cgp 45840b, Voltfast, Cambia, Zipsor
    Molecular Formula
    C14H10Cl2KNO2
    Molecular Weight
    334.2  g/mol
    InChI Key
    KXZOIWWTXOCYKR-UHFFFAOYSA-M
    FDA UNII
    L4D5UA6CB4
    Diclofenac Potassium
    A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
    1 2D Structure

    Diclofenac Potassium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate
    2.1.2 InChI
    InChI=1S/C14H11Cl2NO2.K/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;/h1-7,17H,8H2,(H,18,19);/q;+1/p-1
    2.1.3 InChI Key
    KXZOIWWTXOCYKR-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[K+]
    2.2 Other Identifiers
    2.2.1 UNII
    L4D5UA6CB4
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dichlofenal

    2. Diclofenac

    3. Diclofenac Sodium

    4. Diclofenac, Sodium

    5. Diclonate P

    6. Diclophenac

    7. Dicrofenac

    8. Feloran

    9. Gp 45,840

    10. Gp-45,840

    11. Gp45,840

    12. Novapirina

    13. Orthofen

    14. Orthophen

    15. Ortofen

    16. Sodium Diclofenac

    17. Sr 38

    18. Sr-38

    19. Sr38

    20. Voltaren

    21. Voltarol

    2.3.2 Depositor-Supplied Synonyms

    1. 15307-81-0

    2. Cataflam

    3. Cgp 45840b

    4. Voltfast

    5. Cambia

    6. Zipsor

    7. Diclofenac Potassium [usan:usp]

    8. Potassium Diclofenac

    9. Potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate

    10. Diclofenac (potassium)

    11. Cgp-45840b

    12. Diclofenac Potassium Salt

    13. L4d5ua6cb4

    14. Chebi:4508

    15. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Monopotassium Salt

    16. Potassium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate

    17. Cataflam; Diclofenac Potassium; K-fenak; Potassium Diclofenac; Prosorb

    18. Diclofenac Potassium [usan]

    19. Unii-l4d5ua6cb4

    20. Cataflam (tn)

    21. Potassium (o-(2,6-dichloroanilino)phenyl)acetate

    22. Cambia (tn)

    23. Zipsor (tn)

    24. Diclofenac Potassium (usp)

    25. Schembl40784

    26. Chembl1200804

    27. Dtxsid30165212

    28. Hms3656d18

    29. Diclofenac Potassium [vandf]

    30. Diclofenac Potassium [mart.]

    31. S3062

    32. Diclofenac Potassium [usp-rs]

    33. Diclofenac Potassium [who-dd]

    34. Akos015889752

    35. Akos015994733

    36. Diclofenac Potassium Salt [mi]

    37. Ccg-267848

    38. Ks-5037

    39. Ac-18735

    40. Diclofenac Potassium [orange Book]

    41. Hy-15038

    42. Diclofenac Potassium [ep Monograph]

    43. Db-043176

    44. Diclofenac Potassium [usp Monograph]

    45. Cs-0003712

    46. Ft-0603076

    47. Sw196404-4

    48. D00903

    49. Q27106401

    50. Potassium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

    51. Potassium 2-(2-(2,6-dichlorophenylamino)phenyl)acetate

    52. Potassium (o-((2,6-dichlorophenyl)amino)phenyl)acetate

    53. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid, Monopotassium Salt

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 334.2 g/mol
    Molecular Formula C14H10Cl2KNO2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass332.9725654 g/mol
    Monoisotopic Mass332.9725654 g/mol
    Topological Polar Surface Area52.2 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity310
    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 8  
    Drug NameCambia
    Drug LabelCAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buff...
    Active IngredientDiclofenac potassium
    Dosage FormFor solution
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyDepomed

    2 of 8  
    Drug NameCataflam
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelCataflam (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. Cataflam is available as immediate-release tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benz...
    Active IngredientDiclofenac potassium
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyNovartis

    3 of 8  
    Drug NameDiclofenac potassium
    Drug LabelDiclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,...
    Active IngredientDiclofenac potassium
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyTeva; Apotex; Sandoz; Mylan

    4 of 8  
    Drug NameZipsor
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelZipsor (diclofenac potassium) Liquid Filled Capsule is a benzeneacetic acid derivative NSAID. Zipsor is available as liquid-filled capsules of 25 mg for oral administration. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid mono...
    Active IngredientDiclofenac potassium
    Dosage FormCapsule
    RouteOral
    Strength25mg
    Market StatusPrescription
    CompanyDepomed

    5 of 8  
    Drug NameCambia
    Drug LabelCAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buff...
    Active IngredientDiclofenac potassium
    Dosage FormFor solution
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyDepomed

    6 of 8  
    Drug NameCataflam
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelCataflam (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. Cataflam is available as immediate-release tablets of 50 mg (light brown) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benz...
    Active IngredientDiclofenac potassium
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyNovartis

    7 of 8  
    Drug NameDiclofenac potassium
    Drug LabelDiclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,...
    Active IngredientDiclofenac potassium
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyTeva; Apotex; Sandoz; Mylan

    8 of 8  
    Drug NameZipsor
    PubMed HealthDiclofenac
    Drug ClassesAnalgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent
    Drug LabelZipsor (diclofenac potassium) Liquid Filled Capsule is a benzeneacetic acid derivative NSAID. Zipsor is available as liquid-filled capsules of 25 mg for oral administration. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid mono...
    Active IngredientDiclofenac potassium
    Dosage FormCapsule
    RouteOral
    Strength25mg
    Market StatusPrescription
    CompanyDepomed

    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.)

    Cyclooxygenase Inhibitors

    Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Cyclooxygenase Inhibitors [MoA]; Decreased Prostaglandin Production [PE]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

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    11-Jan-2022
    30-May-2025
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    DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20142

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    DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20142

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    DOSAGE - CAPSULE;ORAL - 25MG

    USFDA APPLICATION NUMBER - 22202

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    ABOUT THIS PAGE

    Looking for 15307-81-0 / Diclofenac Potassium API manufacturers, exporters & distributors?

    Diclofenac Potassium manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Diclofenac Potassium 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 Diclofenac Potassium manufacturer or Diclofenac Potassium supplier for your needs.

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

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

    API | Excipient name

    Diclofenac Potassium

    Synonyms

    15307-81-0, Cataflam, Cgp 45840b, Voltfast, Cambia, Zipsor

    Cas Number

    15307-81-0

    Unique Ingredient Identifier (UNII)

    L4D5UA6CB4

    About Diclofenac Potassium

    A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

    Zipsor Manufacturers

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

    Zipsor Suppliers

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

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

    Zipsor USDMF

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

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

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

    Zipsor KDMF

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

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

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

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

    Zipsor CEP

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

    A Zipsor CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zipsor 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 Zipsor suppliers with CEP (COS) on PharmaCompass.

    Zipsor WC

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

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

    Zipsor 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 Zipsor as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Zipsor GMP

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

    Zipsor CoA

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

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

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