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    Chemistry

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    Also known as: Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia
    Molecular Formula
    C20H24ClNO4
    Molecular Weight
    377.9  g/mol
    InChI Key
    RHBRMCOKKKZVRY-ITLPAZOVSA-N
    FDA UNII
    Z6375YW9SF
    Naltrexone Hydrochloride
    Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.
    1 2D Structure

    Naltrexone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C20H23NO4.ClH/c22-13-4-3-12-9-15-20(24)6-5-14(23)18-19(20,16(12)17(13)25-18)7-8-21(15)10-11-1-2-11;/h3-4,11,15,18,22,24H,1-2,5-10H2;1H/t15-,18+,19+,20-;/m1./s1
    2.1.3 InChI Key
    RHBRMCOKKKZVRY-ITLPAZOVSA-N
    2.1.4 Canonical SMILES
    C1CC1CN2CCC34C5C(=O)CCC3(C2CC6=C4C(=C(C=C6)O)O5)O.Cl
    2.1.5 Isomeric SMILES
    C1CC1CN2CC[C@]34[C@@H]5C(=O)CC[C@]3([C@H]2CC6=C4C(=C(C=C6)O)O5)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    Z6375YW9SF
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Antaxone

    2. Celupan

    3. En 1639a

    4. En-1639a

    5. En1639a

    6. Nalorex

    7. Naltrexone

    8. Nemexin

    9. Revia

    10. Trexan

    2.3.2 Depositor-Supplied Synonyms

    1. Naltrexone Hcl

    2. 16676-29-2

    3. Trexan

    4. Depade

    5. Antaxone

    6. Revia

    7. Naltrexone (hydrochloride)

    8. En-1639a

    9. Nih 8503

    10. Celupan

    11. Nemexin

    12. N-cyclopropylmethyl-noroxymorphone Hydrochloride

    13. Mls000069607

    14. Naltrexone Hydrochloride [usp]

    15. Z6375yw9sf

    16. Vivitrex

    17. 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

    18. Nalorex

    19. Smr000058767

    20. En-1639a (as Hydrochloride)

    21. En 1639a

    22. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

    23. Naltrexone Hydrochloride (usp)

    24. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

    25. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride (1:1), (5alpha)-

    26. Ccris 1168

    27. Einecs 240-723-0

    28. Unii-z6375yw9sf

    29. Naltrel

    30. Naltrexone.hcl

    31. Naltrexone Depot

    32. Prestwick_348

    33. Mfcd00069324

    34. (5alpha)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    35. Revia (tn)

    36. Xr-ntx

    37. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

    38. Opera_id_1828

    39. Naltrexone Monohydrochloride

    40. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

    41. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5-alpha)-

    42. Schembl37713

    43. Mls001076516

    44. Mls002153483

    45. Mls002695940

    46. Cyto-205

    47. Chembl1201149

    48. Dtxsid50937236

    49. Pti-901

    50. Chebi:134687

    51. Bcp08343

    52. Naltrexone Hydrochloride [mi]

    53. S2103

    54. Vp-004

    55. Akos015994597

    56. Ccg-268383

    57. Cs-0763

    58. Hs-0003

    59. Nc00693

    60. 17-cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    61. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-oxy-3,14-dihydoxy-, Hydrochloride

    62. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5alpha)-

    63. Naltrexone Hydrochloride [mart.]

    64. Naltrexone Hydrochloride [vandf]

    65. Naltrexone Hydrochloride [who-dd]

    66. Bn164635

    67. Hy-76710

    68. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5.alpha.)-

    69. N1176

    70. Naltrexone Hydrochloride [green Book]

    71. Sw196619-3

    72. Naltrexone Hydrochloride [orange Book]

    73. D02095

    74. Embeda Component Naltrexone Hydrochloride

    75. H10489

    76. Naltrexone Hydrochloride [ep Monograph]

    77. Naltrexone Hydrochloride [usp Monograph]

    78. Troxyca Component Naltrexone Hydrochloride

    79. 676n292

    80. Contrave Component Naltrexone Hydrochloride

    81. Naltrexone Hydrochloride Component Of Embeda

    82. Naltrexone Hydrochloride Component Of Troxyca

    83. Naltrexone Hydrochloride Component Of Contrave

    84. Q27096434

    85. Z1558290144

    86. Naltrexone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    87. Naltrexone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    88. (5a)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

    89. 17-(cyclopropylmethyl)-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

    90. 17-cyclopropylmethyl)-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

    91. (1s,5r,13r,17s)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one Hydrochloride

    92. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydron;chloride

    93. (5alpha,17r)-17-(cyclopropylmethyl)-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

    94. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5.alpha.)-, Hydrochloride (1:1)

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 377.9 g/mol
    Molecular Formula C20H24ClNO4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass377.1393859 g/mol
    Monoisotopic Mass377.1393859 g/mol
    Topological Polar Surface Area70 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity621
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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 6  
    Drug NameNaltrexone hydrochloride
    PubMed HealthNaltrexone
    Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
    Drug LabelNaltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
    Active IngredientNaltrexone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyAccord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

    2 of 6  
    Drug NameRevia
    PubMed HealthNaltrexone
    Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
    Drug LabelREVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
    Active IngredientNaltrexone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyTeva Womens

    3 of 6  
    Drug NameVivitrol
    Active IngredientNaltrexone
    Dosage FormFor suspension, extended release
    RouteIntramuscular
    Strength380mg/vial
    Market StatusPrescription
    CompanyAlkermes

    4 of 6  
    Drug NameNaltrexone hydrochloride
    PubMed HealthNaltrexone
    Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
    Drug LabelNaltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
    Active IngredientNaltrexone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyAccord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

    5 of 6  
    Drug NameRevia
    PubMed HealthNaltrexone
    Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
    Drug LabelREVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
    Active IngredientNaltrexone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength50mg
    Market StatusPrescription
    CompanyTeva Womens

    6 of 6  
    Drug NameVivitrol
    Active IngredientNaltrexone
    Dosage FormFor suspension, extended release
    RouteIntramuscular
    Strength380mg/vial
    Market StatusPrescription
    CompanyAlkermes

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Alcohol Deterrents

    Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism. (See all compounds classified as Alcohol Deterrents.)

    Narcotic Antagonists

    Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

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    06-May-2022
    29-Jul-2025
    KGS
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    Average Price (USD/KGS)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

    USFDA APPLICATION NUMBER - 200063

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22321

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    ABOUT THIS PAGE

    Looking for 16676-29-2 / Naltrexone Hydrochloride API manufacturers, exporters & distributors?

    Naltrexone Hydrochloride manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Naltrexone Hydrochloride

    Synonyms

    Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia

    Cas Number

    16676-29-2

    Unique Ingredient Identifier (UNII)

    Z6375YW9SF

    About Naltrexone Hydrochloride

    Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

    Celupan Manufacturers

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

    Celupan Suppliers

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

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

    Celupan USDMF

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

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

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

    Celupan KDMF

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

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

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

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

    Celupan CEP

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

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

    Celupan WC

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

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

    Celupan 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 Celupan as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Celupan GMP

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

    Celupan CoA

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

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

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