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    Chemistry

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    Also known as: 25416-65-3, Levothyroxine sodium, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate
    Molecular Formula
    C15H12I4NNaO5
    Molecular Weight
    816.87  g/mol
    InChI Key
    ANMYAHDLKVNJJO-LTCKWSDVSA-M
    FDA UNII
    B82379R9W0
    Thyroxine
    The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.
    1 2D Structure

    Thyroxine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;(2S)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate
    2.1.2 InChI
    InChI=1S/C15H11I4NO4.Na.H2O/c16-8-4-7(5-9(17)13(8)21)24-14-10(18)1-6(2-11(14)19)3-12(20)15(22)23;;/h1-2,4-5,12,21H,3,20H2,(H,22,23);;1H2/q;+1;/p-1/t12-;;/m0../s1
    2.1.3 InChI Key
    ANMYAHDLKVNJJO-LTCKWSDVSA-M
    2.1.4 Canonical SMILES
    C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)CC(C(=O)[O-])N.O.[Na+]
    2.1.5 Isomeric SMILES
    C1=C(C=C(C(=C1I)OC2=CC(=C(C(=C2)I)O)I)I)C[C@@H](C(=O)[O-])N.O.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    B82379R9W0
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3,5,3',5'-tetraiodothyronine

    2. Berlthyrox

    3. Dexnon

    4. Eferox

    5. Eltroxin

    6. Eltroxine

    7. Euthyrox

    8. Eutirox

    9. L Thyrox

    10. L Thyroxin Beta

    11. L Thyroxin Henning

    12. L Thyroxine

    13. L Thyroxine Roche

    14. L-3,5,3',5'-tetraiodothyronine

    15. L-thyrox

    16. L-thyroxin Beta

    17. L-thyroxin Henning

    18. L-thyroxine

    19. L-thyroxine Roche

    20. Lvothyrox

    21. Levo T

    22. Levo-t

    23. Levothroid

    24. Levothyroid

    25. Levothyroxin Deladande

    26. Levothyroxin Delalande

    27. Levothyroxine

    28. Levothyroxine Sodium

    29. Levoxine

    30. Levoxyl

    31. Novothyral

    32. Novothyrox

    33. O-(4-hydroxy-3,5-diiodophenyl) 3,5-diiodo-l-tyrosine

    34. O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine

    35. Oroxine

    36. Sodium Levothyroxine

    37. Synthroid

    38. Synthrox

    39. T4 Thyroid Hormone

    40. Thevier

    41. Thyrax

    42. Thyroid Hormone, T4

    43. Thyroxin

    44. Thyroxine

    45. Tiroidine

    46. Tiroxina Leo

    47. Unithroid

    2.3.2 Depositor-Supplied Synonyms

    1. 25416-65-3

    2. Levothyroxine Sodium

    3. L-thyroxine Sodium Xhydrate

    4. Levothyroxine Sodium Hydrate

    5. L-thyroxine Sodium Hydrate

    6. Monosodium L-thyroxine Hydrate

    7. 31178-59-3

    8. Chebi:6447

    9. Levothroid

    10. Synthroid

    11. Levothyrox

    12. Levaxin

    13. Levoxyl

    14. Oroxine

    15. Soloxine

    16. Eferox

    17. Sodium;(2s)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;hydrate

    18. B82379r9w0

    19. Thyroxine Sodium

    20. Levo-t

    21. Liotrix (t4)

    22. Thyroxine Sodium Salt

    23. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Monohydrate

    24. Latequatro

    25. Letequatro

    26. Levoroxin

    27. Levotiron

    28. Tiroxina

    29. Tivoral

    30. Levo-tiroxina Glaxo

    31. Nsc-259940

    32. L-tyrosine, O-(4-hydroxy-3,5-diiodophenyl)-3,5-diiodo-, Monosodium Salt, Hydrate

    33. Unii-b82379r9w0

    34. Levothroid (tn)

    35. Synthroid (tn)

    36. Levoxyl (tn)

    37. Levothyroxine Sodium [usp:inn:jan]

    38. Starbld0009614

    39. L-thyroxin Monosodium Salt

    40. T4 (liotrix)

    41. Levothyroxine Sodium (usp)

    42. Schembl2327406

    43. Chembl2103741

    44. L-thyroxine Sodium Salt Monohydrate

    45. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt Hydrate

    46. Levothyroxine Sodium Hydrate (jp17)

    47. Mfcd06408007

    48. Akos015895962

    49. Ks-1237

    50. D01010

    51. E78443

    52. Levothyroxine Sodium Monohydrate [who-ip]

    53. 3,3',5,5'-tetraiodo-l-thyronine Monosodium Salt

    54. A817851

    55. Q27107209

    56. Levothyroxinum Natricum Monohydrate [who-ip Latin]

    57. Sodium 2-amino-3-[4-(4-hydroxy-3,5-diiodo-phenoxy)-3,5-diiodo-phenyl]propanoate Hydrate

    58. Sodium (s)-2-amino-3-(4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)propanoate Xhydrate

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 816.87 g/mol
    Molecular Formula C15H12I4NNaO5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass816.6792 g/mol
    Monoisotopic Mass816.6792 g/mol
    Topological Polar Surface Area96.6 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity426
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameLevo-t
    Drug LabelLevothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyAlara Pharm

    2 of 8  
    Drug NameLevothroid
    PubMed HealthThyroid Supplement (By mouth)
    Drug ClassesDiagnostic Agent, Thyroid Function, Thyroid Supplement
    Drug LabelLEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyLloyd

    3 of 8  
    Drug NameLevothyroxine sodium
    Active IngredientLevothyroxine sodium
    Dosage FormTablet; Powder; Injectable
    Routeinjection; Oral; Intravenous
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Mylan

    4 of 8  
    Drug NameLevoxyl
    Drug LabelLEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyKing Pharms R And D

    5 of 8  
    Drug NameLevo-t
    Drug LabelLevothyroxine sodium tablets, USP contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland.Levothyroxine (T4) sodium has an empir
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyAlara Pharm

    6 of 8  
    Drug NameLevothroid
    PubMed HealthThyroid Supplement (By mouth)
    Drug ClassesDiagnostic Agent, Thyroid Function, Thyroid Supplement
    Drug LabelLEVOTHROID (levothyroxine sodium tablets, USP) contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyLloyd

    7 of 8  
    Drug NameLevothyroxine sodium
    Active IngredientLevothyroxine sodium
    Dosage FormTablet; Powder; Injectable
    Routeinjection; Oral; Intravenous
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 200mcg/vial; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 descr
    Market StatusPrescription
    CompanyFresenius Kabi Usa; Mylan

    8 of 8  
    Drug NameLevoxyl
    Drug LabelLEVOXYL (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3,5,5-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodiu...
    Active IngredientLevothyroxine sodium
    Dosage FormTablet
    RouteOral
    Strength0.05mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.112mg **see current annual edition, 1.8 description of special situations, levothyroxine sodium; 0.2mg **see current annual edition, 1.8 description of spe
    Market StatusPrescription
    CompanyKing Pharms R And D

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    l-Thyroxine [EPC]; Thyroxine [CS]
    5.2 ATC Code

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H03 - Thyroid therapy

    H03A - Thyroid preparations

    H03AA - Thyroid hormones

    H03AA01 - Levothyroxine sodium

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 0.05MG **See current A...DOSAGE - TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

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    ABOUT THIS PAGE

    Looking for 31178-59-3 / Levothyroxine Sodium API manufacturers, exporters & distributors?

    Levothyroxine Sodium manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Levothyroxine Sodium

    Synonyms

    25416-65-3, L-thyroxine sodium xhydrate, Levothyroxine sodium hydrate, L-thyroxine sodium hydrate, Monosodium l-thyroxine hydrate, 31178-59-3

    Cas Number

    31178-59-3

    Unique Ingredient Identifier (UNII)

    B82379R9W0

    About Levothyroxine Sodium

    The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

    Novothyral Manufacturers

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

    Novothyral Suppliers

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

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

    Novothyral USDMF

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

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

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

    Novothyral 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 Novothyral Drug Master File in Japan (Novothyral JDMF) empowers Novothyral 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 Novothyral JDMF during the approval evaluation for pharmaceutical products. At the time of Novothyral 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 Novothyral suppliers with JDMF on PharmaCompass.

    Novothyral KDMF

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

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

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

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

    Novothyral CEP

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

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

    Novothyral WC

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

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

    Novothyral 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 Novothyral as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Novothyral GMP

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

    Novothyral CoA

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

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

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