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    Chemistry

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    Also known as: 175591-09-0, Tapentadol hcl, Nucynta, Palexia, Tapentadol (hydrochloride), Nucynta er
    Molecular Formula
    C14H24ClNO
    Molecular Weight
    257.80  g/mol
    InChI Key
    ZELFLGGRLLOERW-YECZQDJWSA-N
    FDA UNII
    71204KII53
    Tapentadol
    An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.
    1 2D Structure

    Tapentadol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride
    2.1.2 InChI
    InChI=1S/C14H23NO.ClH/c1-5-14(11(2)10-15(3)4)12-7-6-8-13(16)9-12;/h6-9,11,14,16H,5,10H2,1-4H3;1H/t11-,14+;/m0./s1
    2.1.3 InChI Key
    ZELFLGGRLLOERW-YECZQDJWSA-N
    2.1.4 Canonical SMILES
    CCC(C1=CC(=CC=C1)O)C(C)CN(C)C.Cl
    2.1.5 Isomeric SMILES
    CC[C@@H](C1=CC(=CC=C1)O)[C@@H](C)CN(C)C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    71204KII53
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol

    2. Nucynta

    3. Tapentadol

    2.3.2 Depositor-Supplied Synonyms

    1. 175591-09-0

    2. Tapentadol Hcl

    3. Nucynta

    4. Palexia

    5. Tapentadol (hydrochloride)

    6. Nucynta Er

    7. Bn-200 Hydrochloride

    8. Cg5503 Hydrochloride

    9. Cg-5503 Hydrochloride

    10. 3-((2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl)phenol Hydrochloride

    11. 71204kii53

    12. 175591-09-0 (hcl)

    13. Tapentadol Hydrochloride (jan)

    14. Tapentadol Hydrochloride [jan]

    15. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride

    16. Palexia Retard

    17. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol Hydrochloride

    18. Unii-71204kii53

    19. Palexia Sr

    20. Phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, Hydrochloride (1:1)

    21. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride (1:1)

    22. Nucynta (tn)

    23. Schembl238138

    24. Jns-024 Er

    25. Chembl1201777

    26. Dtxsid00938677

    27. Amy25232

    28. Hy-70042a

    29. Mfcd00944992

    30. Tapentadol Hydrochloride [mi]

    31. Akos016842888

    32. Cs-0879

    33. Tapentadol Hydrochloride [mart.]

    34. Tapentadol Hydrochloride [vandf]

    35. Tapentadol Hydrochloride [who-dd]

    36. Ac-32018

    37. Tapentadol Hydrochloride [orange Book]

    38. D10199

    39. Tapentadol Hydrochloride [ep Monograph]

    40. 591t238

    41. Tapentadol Hydrochloride (1.0 Mg/ml In Methanol)

    42. R-331333

    43. Q27265914

    44. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl) Phenol Hydrochloride

    45. 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol Hydrochloride

    46. 3-[(2r,3r)-1-(dimethylamino)-2-methylpentan-3-yl]phenol;hydrochloride

    47. 3-[1-(dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen Chloride (1/1)

    48. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol Hydrochloride

    49. (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol Hydrochloride

    50. 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol Monohydrochloride

    51. Phenol, 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride

    52. Phenol, 3-(3-(dimethylamino)-1-ethyl-2-methylpropyl)-, Hydrochloride, (r-(r*,r*))-

    53. Tapentadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 257.80 g/mol
    Molecular Formula C14H24ClNO
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count5
    Exact Mass257.1546421 g/mol
    Monoisotopic Mass257.1546421 g/mol
    Topological Polar Surface Area23.5 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity193
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 4  
    Drug NameNucynta
    PubMed HealthTapentadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelNUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
    Active IngredientTapentadol hydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 4  
    Drug NameNucynta er
    Drug LabelNUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
    Active IngredientTapentadol hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base
    Market StatusPrescription
    CompanyJanssen Pharms

    3 of 4  
    Drug NameNucynta
    PubMed HealthTapentadol (By mouth)
    Drug ClassesAnalgesic
    Drug LabelNUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
    Active IngredientTapentadol hydrochloride
    Dosage FormTablet; Solution
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 75mg base; eq 20mg base/ml
    Market StatusPrescription
    CompanyJanssen Pharms

    4 of 4  
    Drug NameNucynta er
    Drug LabelNUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, correspo...
    Active IngredientTapentadol hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 250mg base; eq 150mg base; eq 200mg base
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Drug Indication

    Treatment of acute pain

    Treatment of acute pain

    Treatment of acute pain

    Treatment of chronic pain

    Treatment of chronic pain

    Treatment of acute pain

    Treatment of chronic pain

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic Uptake Inhibitors

    Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)

    Analgesics, Opioid

    Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Agonists [MoA]; Opioid Agonist [EPC]

    API Reference Price

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    21-Jan-2022
    25-Feb-2026
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 200533

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

    USFDA APPLICATION NUMBER - 200533

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

    USFDA APPLICATION NUMBER - 200533

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE

    USFDA APPLICATION NUMBER - 200533

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 200533

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    DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Fe...DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 203794

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    DOSAGE - TABLET;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 22304

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 22304

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    DOSAGE - TABLET;ORAL - EQ 75MG BASE

    USFDA APPLICATION NUMBER - 22304

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    ABOUT THIS PAGE

    Looking for 175591-09-0 / Tapentadol API manufacturers, exporters & distributors?

    Tapentadol manufacturers, exporters & distributors 1

    87

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

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

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

    API | Excipient name

    Tapentadol

    Synonyms

    175591-09-0, Tapentadol hcl, Nucynta, Palexia, Tapentadol (hydrochloride), Nucynta er

    Cas Number

    175591-09-0

    Unique Ingredient Identifier (UNII)

    71204KII53

    About Tapentadol

    An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.

    Nucynta Manufacturers

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

    Nucynta Suppliers

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

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

    Nucynta USDMF

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

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

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

    Nucynta KDMF

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

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

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

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

    Nucynta CEP

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

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

    Nucynta WC

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

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

    Nucynta 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 Nucynta as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Nucynta GMP

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

    Nucynta CoA

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

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

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