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    Chemistry

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    Also known as: Corgard, 42200-33-9, Solgol, (2r,3s)-5-[3-(tert-butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydronaphthalene-2,3-diol, Sq-11725, Anabet
    Molecular Formula
    C17H27NO4
    Molecular Weight
    309.4  g/mol
    InChI Key
    VWPOSFSPZNDTMJ-UCWKZMIHSA-N
    FDA UNII
    FEN504330V
    Nadolol
    A non-selective beta-adrenergic antagonist with a long half-life, used in cardiovascular disease to treat arrhythmias, angina pectoris, and hypertension. Nadolol is also used for MIGRAINE DISORDERS and for tremor.
    Nadolol is a beta-Adrenergic Blocker. The mechanism of action of nadolol is as an Adrenergic beta-Antagonist.
    1 2D Structure

    Nadolol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3S)-5-[3-(tert-butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydronaphthalene-2,3-diol
    2.1.2 InChI
    InChI=1S/C17H27NO4/c1-17(2,3)18-9-12(19)10-22-16-6-4-5-11-7-14(20)15(21)8-13(11)16/h4-6,12,14-15,18-21H,7-10H2,1-3H3/t12?,14-,15+/m1/s1
    2.1.3 InChI Key
    VWPOSFSPZNDTMJ-UCWKZMIHSA-N
    2.1.4 Canonical SMILES
    CC(C)(C)NCC(COC1=CC=CC2=C1CC(C(C2)O)O)O
    2.1.5 Isomeric SMILES
    CC(C)(C)NCC(COC1=CC=CC2=C1C[C@@H]([C@@H](C2)O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    FEN504330V
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Corgard

    2. Solgol

    3. Sq 11725

    4. Sq-11725

    5. Sq11725

    2.3.2 Depositor-Supplied Synonyms

    1. Corgard

    2. 42200-33-9

    3. Solgol

    4. (2r,3s)-5-[3-(tert-butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydronaphthalene-2,3-diol

    5. Sq-11725

    6. Anabet

    7. (2r,3s)-5-(3-(tert-butylamino)-2-hydroxypropoxy)-1,2,3,4-tetrahydronaphthalene-2,3-diol

    8. Nadolol [mi]

    9. Nadolol [hsdb]

    10. Nadolol [inn]

    11. Nadolol [jan]

    12. Nadolol [usan]

    13. Nadolol [vandf]

    14. Nadolol [mart.]

    15. Nadolol [who-dd]

    16. Corzide Component Nadolol

    17. Chembl649

    18. Nadolol [orange Book]

    19. Nsc-758430

    20. Nadolol Component Of Corzide

    21. Nadolol [usp Monograph]

    22. Mls000028580

    23. Fen504330v

    24. Smr000058975

    25. Dsstox_cid_3342

    26. Dsstox_rid_76983

    27. Dsstox_gsid_23342

    28. 1403-22-1

    29. 1-(tert-butylamino)-3-((5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy)-2-propanol

    30. Cis-5-(3-((1,1-dimethylethyl)amino)-2-hydroxy-propoxy)-1,2,3,4-tetrahydro-2,3-naphthalenediol

    31. Sr-01000000251

    32. 2,3-naphthalenediol, 5-(3-((1,1-dimethylethyl)amino)-2-hydroxypropoxy)-1,2,3,4-tetrahydro-, Cis-

    33. Sq11725

    34. Unii-fen504330v

    35. Candidin B

    36. Ncgc00016851-01

    37. 220045-89-6

    38. Prestwick_108

    39. Nadolol [ep]

    40. Nadolol [usp]

    41. Cas-42200-33-9

    42. Nadolol [usp-rs]

    43. Spectrum_001643

    44. Opera_id_1099

    45. Prestwick0_000818

    46. Prestwick1_000818

    47. Prestwick2_000818

    48. Spectrum2_001546

    49. Spectrum3_001586

    50. Spectrum4_000193

    51. Spectrum5_001255

    52. Schembl4177

    53. Nadolol, Analytical Standard

    54. Bspbio_003152

    55. Gtpl554

    56. Kbiogr_000765

    57. Kbioss_002123

    58. Cid_39147

    59. Mls001148087

    60. Mls002548875

    61. Divk1c_000427

    62. Nadolol (jp17/usp/inn)

    63. Nadolol [ep Impurity]

    64. Spectrum1503260

    65. Spbio_001392

    66. Spbio_002636

    67. Nadolol [ep Monograph]

    68. Inv102

    69. Nadolol 1.0 Mg/ml In Methanol

    70. Bdbm25766

    71. Hms501f09

    72. Kbio1_000427

    73. Kbio2_002123

    74. Kbio2_004691

    75. Kbio2_007259

    76. Kbio3_002652

    77. Inv-102

    78. Ninds_000427

    79. Hms1570d17

    80. Hms1922o05

    81. Hms2093a15

    82. Hms2233e12

    83. Hms3259c07

    84. Hms3714d17

    85. Pharmakon1600-01503260

    86. Tox21_110646

    87. Ccg-39324

    88. Nsc758430

    89. S5023

    90. Akos015895037

    91. Tox21_110646_1

    92. Db01203

    93. Nc00464

    94. Idi1_000427

    95. Smp1_000203

    96. Ncgc00021623-03

    97. Ncgc00021623-05

    98. Ncgc00089811-02

    99. (2r,3s)-5-({3-[(1,1-dimethylethyl)amino]-2-hydroxypropyl}oxy)-1,2,3,4-tetrahydronaphthalene-2,3-diol

    100. Sbi-0051806.p002

    101. En300-50860

    102. Vu0239635-6

    103. A12516

    104. D00432

    105. Ab00052338_13

    106. 200n339

    107. Q424952

    108. Sr-01000000251-2

    109. Sr-01000000251-3

    110. Brd-a87606379-001-03-4

    111. Brd-a87606379-001-13-3

    112. Nadolol, European Pharmacopoeia (ep) Reference Standard

    113. Nadolol, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 309.4 g/mol
    Molecular Formula C17H27NO4
    XLogP30.7
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass309.19400834 g/mol
    Monoisotopic Mass309.19400834 g/mol
    Topological Polar Surface Area82 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity344
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCorgard
    PubMed HealthNadolol (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Antimigraine, Cardiovascular Agent
    Drug LabelCORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula:C17H27NO4MW 309...
    Active IngredientNadolol
    Dosage FormTablet
    RouteOral
    Strength80mg; 40mg; 20mg
    Market StatusPrescription
    CompanyKing Pharms

    2 of 4  
    Drug NameNadolol
    PubMed HealthNadolol (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Antimigraine, Cardiovascular Agent
    Drug LabelNadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Its structural formula is:Nadolol is a white crystalline pow...
    Active IngredientNadolol
    Dosage FormTablet
    RouteOral
    Strength80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySandoz; Ivax Sub Teva Pharms; Mylan

    3 of 4  
    Drug NameCorgard
    PubMed HealthNadolol (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Antimigraine, Cardiovascular Agent
    Drug LabelCORGARD (nadolol) is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula:C17H27NO4MW 309...
    Active IngredientNadolol
    Dosage FormTablet
    RouteOral
    Strength80mg; 40mg; 20mg
    Market StatusPrescription
    CompanyKing Pharms

    4 of 4  
    Drug NameNadolol
    PubMed HealthNadolol (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Antimigraine, Cardiovascular Agent
    Drug LabelNadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1-naphthyl)oxy]-2-propanol. Its structural formula is:Nadolol is a white crystalline pow...
    Active IngredientNadolol
    Dosage FormTablet
    RouteOral
    Strength80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySandoz; Ivax Sub Teva Pharms; Mylan

    4.2 Therapeutic Uses

    Adrenergic beta-Antagonists; Anti-Arrhythmia Agents; Antihypertensive Agents; Sympatholytics

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    ... Nadolol /is/ indicated in the treatment of hypertension when used alone or in combination with other antihypertensive medication. ... /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 550

    Nadolol has been used in a limited number of patients with atrial flutter or fibrillation for the management of frequent ventricular premature contractions, paroxysmal atrial tachycardia, and sinus tachycardia and to decrease heart rate. Nadolol has been used with some success in a limited number of patients for the prophylaxis of common migraine headache.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1771

    /Exptl/ This investigation reports pilot data on two points originally raised in the earliest reports of the efficacy of beta-blockers in akathisia: their potential utility in the akathisia of idiopathic Parkinson's disease and the possibility of determining a central vs a peripheral site of action by comparing the time course of the effects of lipophilic and hydrophilic agents. Akathisia improved in 4 patients with idiopathic Parkinson's disease after low dose propranolol treatment. Six patients with neuroleptic induced akathisia were treated with the hydrophilic beta-blocker nadolol. Effects on akathisia occurred, but evolved much more slowly than after treatment with lipophilic agents, such as propranolol and metoprolol, thus suggesting a central site of action.

    Adler LA et al; Psychopharmacol Bul 27 (2): 107-11 (1991)

    For more Therapeutic Uses (Complete) data for NADOLOL (16 total), please visit the HSDB record page.

    4.3 Drug Warning

    Nadolol is contraindicated in patients with bronchial asthma, sinus bradycardia and heart block greater than first degree, cardiogenic shock, or overt cardiac failure.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1773

    Nadolol should be used with caution in patients with renal or hepatic impairment, and it may be necessary to reduce the dosage of the drug in those with renal impairment.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1773

    Signs of hyperthyroidism (eg, tachycardia) may be masked by nadolol, and patients having or suspected of developing thyrotoxicosis should be monitored closely because abrupt withdrawal of beta-adrenergic blockade might precipitate thyroid storm. It is recommended that nadolol be used with caution in patients with diabetes mellitus (especially those with labile diabetes or those prone to hypoglycemia) since the drug may also mask the signs and symptoms associated with acute hypoglycemia (eg, tachycardia and blood pressure changes but not sweating), the drug should be used with caution in patients with diabetes mellitus receiving hypoglycemic agents, especially in those with labile disease or those prone to hypoglycemia. Beta-adrenergic blocking agents may also impair glucose tolerance; delay the rate of recovery of blood glucose concentration following drug-induced hypoglycemia; alter the hemodynamic response to hypoglycemia, possibly resulting in an exaggerated hypertensive response; and possibly impair peripheral circulation. If nadolol is used in diabetic patients receiving hypoglycemic agents, it may be necessary to adjust the dosage of the hypoglycemic agent. In one study in nondiabetic patients, nadolol therapy did not produce changes in glucose tolerance.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1773

    Nadolol is distributed into milk. Because of the potential for adverse reactions to nadolol in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1773

    For more Drug Warnings (Complete) data for NADOLOL (10 total), please visit the HSDB record page.

    4.4 Drug Indication

    Nadolol is indicated to treat angina pectoris and hypertension. Another product formulated with [bendroflumethiazide] is indicated to treat hypertension.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Nadolol is a nonselective beta adrenal receptor blocker that is used to lower blood pressure. It has a long duration of action as it is usually taken once daily and a wide therapeutic index as patients start at doses of 40mg daily but may be increased to doses as high as 240mg daily. Patients taking nadolol should not aburptly stop taking it as this may lead to exacerbation of ischemic heart disease.

    5.2 MeSH Pharmacological Classification

    Adrenergic beta-Antagonists

    Drugs that bind to but do not activate beta-adrenergic receptors thereby blocking the actions of beta-adrenergic agonists. Adrenergic beta-antagonists are used for treatment of hypertension, cardiac arrhythmias, angina pectoris, glaucoma, migraine headaches, and anxiety. (See all compounds classified as Adrenergic beta-Antagonists.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    Sympatholytics

    Drugs that inhibit the actions of the sympathetic nervous system by any mechanism. The most common of these are the ADRENERGIC ANTAGONISTS and drugs that deplete norepinephrine or reduce the release of transmitters from adrenergic postganglionic terminals (see ADRENERGIC AGENTS). Drugs that act in the central nervous system to reduce sympathetic activity (e.g., centrally acting alpha-2 adrenergic agonists, see ADRENERGIC ALPHA-AGONISTS) are included here. (See all compounds classified as Sympatholytics.)

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    NADOLOL
    5.3.2 FDA UNII
    FEN504330V
    5.3.3 Pharmacological Classes
    beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]
    5.4 ATC Code

    C - Cardiovascular system

    C07 - Beta blocking agents

    C07A - Beta blocking agents

    C07AA - Beta blocking agents, non-selective

    C07AA12 - Nadolol

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral doses of nadolol are approximately 30% absorbed. In healthy subjects, nadolol has a Tmax of 2.7h with a Cmax or 6915ng/mL following a 60mg oral dose and 13227ng/mL after a 120mg oral dose. The AUC following a 60mg oral dose was 1021ng\*h/mL and following a 120mg oral dose was 1913382ng\*h/mL.

    Route of Elimination

    Nadolol is not metabolized in the liver and excreted mainly in the urine. In healthy subjects, following intravenous dosing, 60% of a dose is eliminated in the urine and 15% in the feces after 72 hours. The remainder of the dose is expected to be eliminated in the feces afterwards.

    Volume of Distribution

    In healthy subjects, the volume of distribution of nadolol is 147-157L.

    Clearance

    In healthy subjects, the total body clearance of nadolol is 219-250mL/min and the renal clearance is 131-150mL/min.

    Following oral administration of nadolol, absorption is variable and averages about 30-40% of a dose. The presence of food in the GI tract does not affect the rate or extent of absorption. After oral administration of 2 mg of nadolol (in a capsule), peak plasma concentrations usually occur in 2-4 hours. In one study in hypertensive adults who received 80 mg, 160 mg, or 320 mg of nadolol daily, mean steady state plasma concentrations were 25.5-35.5 ng/ml, 51.7-74.1 ng/ml, and 154-191.4 ng/ml, respectively. With doses of 40-320 mg daily, the duration of nadolol's antihypertensive and antianginal effects is at least 24 hours.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    Following oral administration of 2 mg of radiolabeled nadolol (in a capsule) in one study in patients with normal renal function, about 24.6% and 76.9% of the radioactivity was recovered in urine and feces, respectively, in 4 days.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    Nadolol is widely distributed into body tissues. In dogs, minimal amounts of nadolol were detected in the brain and, in rats, the drug crosses the placenta. The drug is distributed into bile. Nadolol is distributed into milk. About 30% of nadolol in serum is bound to plasma proteins.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    The beta-adrenoceptor antagonists ... are adequately absorbed, and some like atenolol, sotalol and nadolol which are poorly lipid-soluble are excreted unchanged in the urine, accumulating in renal failure but cleared normally in liver disease. The more lipid-soluble drugs are subject to variable metabolism in the liver, which may be influenced by age, phenotype, environment, disease and other drugs, leading to more variable plasma concentrations. Their clearance is reduced in liver disease but is generally unchanged in renal dysfunction. All the beta-adrenoceptor antagonists reduce cardiac output and this may reduce hepatic clearance of highly extracted drugs. In addition, the metabolised drugs compete with other drugs for enzymatic biotransformation and the potential for interaction is great, but because of the high therapeutic index of beta-adrenoceptor antagonists, any unexpected clinical effects are more likely to be due to changes in the kinetics of the other drug.

    PMID:2886244 Riddell JG et al; Clin Pharmacokinet 12 (5): 305-20 (1987)

    Nadolol 20 mg was administered orally as a single-blind, single dose to nine patients about to undergo cataract extraction. Intraocular pressures fell by a mean of 24% 3 hr after administration. During the operation, aqueous humor and serum samples were taken for measurement of nadolol concentrations. Aqueous nadolol concentrations ranged from 3.8 to 13.4 ng/mL, and correlated with the serum drug concentrations (r=0.84). The fall in intraocular pressure did not correlate with either the aqueous humor or plasma concentrations of nadolol.

    PMID:3203065 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1386505 Tiong T et al; Br J Clin Pharmacol 26 (1): 92-5 (1988)

    5.6 Metabolism/Metabolites

    Nadolol is not metabolized by the liver in humans.

    Nadolol is not metabolized.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    5.7 Biological Half-Life

    The half life of nadolol is 20 to 24 hours.

    The elimination half-life of nadolol is 18 hr. /From table/

    Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997., p. 525

    In patients with normal renal function, the plasma half-life of nadolol is 10-24 hr and, with once daily doses, steady state is attained in 6-9 days. In patients with renal impairment, plasma half-life is increased.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    5.8 Mechanism of Action

    Although nadolol is described as a non selective beta blocker, it does not interact with beta 3 adrenal receptors. Antagonism of beta-1 and beta-2 adrenoceptors in the heart inhibits cyclic AMP and its signalling pathway, decreasing the strength and speed of contractions as well as the speed of relaxation and conduction. Antagonism of beta-2 adrenoceptors in the smooth muscle cells of the vasculature inhibits their relaxation, leading to an increase in peripheral vascular resistance and reducing the risk of severe hypotension. The increase in peripheral vascular resistance may contribute to the decrease in insulin sensitivity associated with nadolol use. Antagonism of beta-1 adrenoceptors in the juxtaglomerular apparatus of the kidney inhibits the release of renin, and therefore angiotensin II mediated vasoconstriction, aldosterone mediated water retention, and the release of epinephrine. Antagonism of beta-2 adrenoceptors in the liver and skeletal muscle inhibits glycogenolysis, in the lungs prevents bronchodilation, and in the pancrease inhibits insulin release.

    Nadolol inhibits response to adrenergic stimuli by competitively blocking beta1-adrenergic receptors within the myocardium and beta2-adrenergic receptors within bronchial and vascular smooth muscle.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    In the management of angina pectoris, the mechanism of action of nadolol is thought to be blockade of catecholamine induced increases in heart rate, velocity and extent of myocardial contraction, and blood pressure which result in a net decrease in myocardial oxygen consumption. However, nadolol may increase oxygen requirements by increasing left ventricular fiber length and end diastolic pressure, particularly in patients with heart failure.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    Through its beta-adrenergic blocking action, nadolol increases airway resistance (especially in asthmatic patients) and inhibits the release of free fatty acids and insulin by adrenergic stimulation.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

    It has been postulated that beta-adrenergic blocking agents reduce blood pressure by blocking peripheral (especially cardiac) adrenergic receptors (decreasing cardiac output), by decreasing sympathetic outflow from the CNS, and/or by suppressing renin release. Nadolol decreases blood pressure in both supine and standing positions.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1774

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BOX 28, 02101 FI ES POO FINLAND FINLAND","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681237800,"product":"NADOLOL RELATED COMPOUND A (QTY: 12 X 25 MG, VALUE: USD 790\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0003","unit":"KGS","unitRateFc":"31600000","totalValueFC":"9951.2","currency":"USD","unitRateINR":"2718463300","date":"12-Apr-2023","totalValueINR":"815538.99","totalValueInUsd":"9951.2","indian_port":"HYDERABAD AIR","hs_no":"29095090","bill_no":"5475136","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681237800,"product":"NADOLOL (QTY: 1 X 200 MG, VALUE: USD 265)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"1325000","totalValueFC":"278.2","currency":"USD","unitRateINR":"113986200","date":"12-Apr-2023","totalValueINR":"22797.24","totalValueInUsd":"278.2","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"5475136","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688581800,"product":"NADOLOL--MATERIAL--116640","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI (HELSINGFORS)","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"900","totalValueFC":"113677.8","currency":"USD","unitRateINR":"74745","date":"06-Jul-2023","totalValueINR":"9343125","totalValueInUsd":"113677.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29221990","bill_no":"1002863","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI (HELSINGFORS)","supplierAddress":"KOIVU-MANKKAAN TIE 6 A FI-02200 ESP OO FINLAND P.O. BOX 28,02101 FI ESP OO FINLAND FINLAND","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694629800,"product":"NADOLOL USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"8.63","actualQuantity":"8.63","unit":"KGS","unitRateFc":"1000","totalValueFC":"8727.9","currency":"USD","unitRateINR":"83950","date":"14-Sep-2023","totalValueINR":"724488.5","totalValueInUsd":"8727.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7830262","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"KOIVU-MANKKAAN TIE 6 A02200 ESPOOSDNFSDNF FINLAND","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706898600,"product":"NADOLOL","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"623.9","totalValueFC":"63235.3","currency":"USD","unitRateINR":"52468.8","date":"03-Feb-2024","totalValueINR":"5246875","totalValueInUsd":"63235.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29221990","bill_no":"1000443","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"AV. INDUSTRIA AUTOMOTRIZ NO. 301COL. ZONA INDUSTRIAL TOLUCATOLUCA","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"NADOLOL USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"1000","totalValueFC":"60516.1","currency":"USD","unitRateINR":"84600","date":"03-Aug-2024","totalValueINR":"5076000","totalValueInUsd":"60516.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4855645","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"KOIVU-MANKKAAN TIE 6 A02200 ESPOOSDNFSDNF FINLAND","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"NADOLOL NADOLOL","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"196.70","actualQuantity":"196.7","unit":"KGS","unitRateFc":"625","totalValueFC":"124142.3","currency":"USD","unitRateINR":"53031.3","date":"09-Oct-2024","totalValueINR":"10431246.88","totalValueInUsd":"124142.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29221990","bill_no":"6027620","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV. INDUSTRIA AUTOMOTRIZ NO 301 50071 TOLUCA, EDO. DE MEXICO CP 50071 MX","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"NADOLOL NADOLOL","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"APOTEX INC","supplierCountry":"MEXICO","foreign_port":"MEXICO CITY","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"346.36","actualQuantity":"346.36","unit":"KGS","unitRateFc":"625","totalValueFC":"218596.4","currency":"USD","unitRateINR":"53031.3","date":"09-Oct-2024","totalValueINR":"18367903.75","totalValueInUsd":"218596.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29221990","bill_no":"6027620","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"MEXICO CITY","supplierAddress":"AV. INDUSTRIA AUTOMOTRIZ NO 301 50071 TOLUCA, EDO. DE MEXICO CP 50071 MX","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
    19-Jan-2021
    18-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 18063

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    DOSAGE - TABLET;ORAL - 40MG

    USFDA APPLICATION NUMBER - 18063

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    DOSAGE - TABLET;ORAL - 80MG

    USFDA APPLICATION NUMBER - 18063

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    DOSAGE - TABLET;ORAL - 5MG;40MG **Federal Reg...DOSAGE - TABLET;ORAL - 5MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18647

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    DOSAGE - TABLET;ORAL - 5MG;80MG **Federal Reg...DOSAGE - TABLET;ORAL - 5MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18647

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    USP

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    ABOUT THIS PAGE

    Nadolol Manufacturers

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

    Nadolol Suppliers

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

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

    Nadolol USDMF

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

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

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

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

    Nadolol CEP

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

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

    Nadolol WC

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

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

    Nadolol 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 Nadolol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Nadolol GMP

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

    Nadolol CoA

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

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

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