levothyroxine Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
2646 51-48-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • levothyroxine sodium anhydrous
  • levothyroxine sodium pentahydrate
  • L-Thyroxine
  • thyroxin sodium
  • thyroxine sodium
  • levothyroxine sodium
  • tetraiodothyronine
  • thyroxine
  • levothyroxine
  • levothyroxin natrium
  • T4
  • levothyroxine sodium hydrate
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.
  • Molecular weight: 776.87
  • Formula: C15H11I4NO4
  • CLOGP: 3.51
  • LIPINSKI: 1
  • HAC: 5
  • HDO: 3
  • TPSA: 92.78
  • ALOGS: -4.94
  • ROTB: 5

Drug dosage:

DoseUnitRoute
0.15 mg O
0.15 mg P

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2000 FDA STEVENS J

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Blood thyroid stimulating hormone increased 1692.27 22.42 296 5711 1095 3378757
Completed suicide 1441.44 22.42 466 5541 30648 3349204
Blood thyroid stimulating hormone abnormal 706.47 22.42 107 5900 97 3379755
Product substitution issue 665.66 22.42 187 5820 7413 3372439
Fatigue 661.24 22.42 386 5621 106854 3272998
Hyperthyroidism 636.91 22.42 148 5859 2686 3377166
Hypothyroidism 594.22 22.42 162 5845 5727 3374125
Product quality issue 557.74 22.42 223 5784 26512 3353340
Drug ineffective 482.48 22.42 326 5681 115764 3264088
Alopecia 464.76 22.42 178 5829 18808 3361044
Thyroid function test abnormal 440.54 22.42 85 5922 585 3379267
Palpitations 431.78 22.42 169 5838 18914 3360938
Drug interaction 408.91 22.42 213 5794 46599 3333253
Toxicity to various agents 379.37 22.42 203 5804 46851 3333001
Blood thyroid stimulating hormone decreased 378.73 22.42 75 5932 600 3379252
Drug hypersensitivity 339.05 22.42 172 5835 35508 3344344
Weight increased 310.90 22.42 148 5859 26592 3353260
Nausea 289.08 22.42 252 5755 129393 3250459
Hypotension 286.25 22.42 172 5835 49342 3330510
Overdose 282.98 22.42 150 5857 33828 3346024
Feeling abnormal 282.75 22.42 140 5867 27385 3352467
Headache 281.01 22.42 215 5792 91765 3288087
Therapeutic response unexpected 280.55 22.42 88 5919 5080 3374772
Malaise 276.16 22.42 186 5821 64991 3314861
Dizziness 253.76 22.42 188 5819 76324 3303528
Foetal exposure during pregnancy 233.71 22.42 103 5904 15448 3364404
Intentional overdose 226.08 22.42 100 5907 15125 3364727
Asthenia 223.49 22.42 164 5843 65501 3314351
Rash 221.25 22.42 168 5839 70653 3309199
Insomnia 218.34 22.42 129 5878 35769 3344083
Hyperhidrosis 195.62 22.42 104 5903 23506 3356346
Circulatory collapse 192.75 22.42 69 5938 5980 3373872
Hypersensitivity 190.10 22.42 108 5899 27792 3352060
Abortion spontaneous 186.76 22.42 79 5928 10706 3369146
Anxiety 186.56 22.42 121 5886 39508 3340344
Therapeutic response changed 180.91 22.42 36 5971 295 3379557
Pruritus 177.48 22.42 125 5882 46708 3333144
Dyspnoea 176.01 22.42 173 5834 102761 3277091
Tremor 175.88 22.42 103 5904 28041 3351811
Heart rate increased 173.60 22.42 82 5925 14404 3365448
Suicide attempt 166.59 22.42 82 5925 15765 3364087
Drug dispensing error 164.89 22.42 55 5952 3853 3375999
Weight decreased 161.13 22.42 111 5896 40000 3339852
Vomiting 155.75 22.42 152 5855 89379 3290473
Brain death 150.70 22.42 37 5970 848 3379004
Constipation 149.62 22.42 96 5911 30716 3349136
Myalgia 146.10 22.42 96 5911 31979 3347873
Drug intolerance 145.06 22.42 68 5939 11730 3368122
Diarrhoea 145.03 22.42 157 5850 104191 3275661
Hypertension 144.06 22.42 102 5905 38364 3341488
Atrial fibrillation 142.64 22.42 85 5922 23856 3355996
Tachycardia 141.92 22.42 84 5923 23287 3356565
Thyroid disorder 141.63 22.42 40 5967 1597 3378255
Urticaria 140.69 22.42 90 5917 28637 3351215
Lethargy 139.80 22.42 70 5937 13945 3365907
Coeliac disease 133.09 22.42 35 5972 1064 3378788
Fall 123.39 22.42 111 5896 58772 3321080
Nervousness 122.55 22.42 50 5957 6174 3373678
Drug effect decreased 117.05 22.42 59 5948 11910 3367942
Maternal exposure during pregnancy 116.44 22.42 56 5951 10215 3369637
Depression 112.14 22.42 89 5918 39681 3340171
Cardiac arrest 110.50 22.42 76 5931 27243 3352609
Bradycardia 109.28 22.42 63 5944 16606 3363246
Thyroxine increased 109.00 22.42 20 5987 100 3379752
Condition aggravated 106.77 22.42 86 5921 39147 3340705
Blood pressure increased 102.25 22.42 67 5940 22163 3357689
Abdominal discomfort 102.00 22.42 63 5944 18821 3361031
Thyroxine decreased 100.20 22.42 19 5988 117 3379735
Muscle spasms 99.82 22.42 71 5936 26832 3353020
Arthralgia 99.39 22.42 100 5907 60761 3319091
Muscular weakness 97.70 22.42 63 5944 20278 3359574
Dysgeusia 96.37 22.42 51 5956 11373 3368479
Abdominal distension 96.21 22.42 54 5953 13522 3366330
Feeling jittery 94.56 22.42 32 5975 2339 3377513
Pain 94.51 22.42 105 5902 71452 3308400
Feeling cold 93.22 22.42 36 5971 3844 3376008
Cardio-respiratory arrest 92.35 22.42 55 5952 15385 3364467
Dysphagia 92.25 22.42 60 5947 19591 3360261
Respiratory arrest 90.97 22.42 49 5958 11319 3368533
Chest pain 90.38 22.42 79 5928 40196 3339656
Dry skin 89.60 22.42 43 5964 7800 3372052
Somnolence 86.32 22.42 70 5937 32134 3347718
Gait disturbance 86.11 22.42 66 5941 27926 3351926
Hip fracture 84.87 22.42 37 5970 5378 3374474
Abdominal pain 84.83 22.42 81 5926 46144 3333708
Exposure during pregnancy 84.82 22.42 65 5942 27498 3352354
Syncope 84.52 22.42 63 5944 25570 3354282
Cough 83.09 22.42 75 5932 39783 3340069
Incorrect dose administered 81.73 22.42 49 5958 13865 3365987
Irritability 80.51 22.42 45 5962 11171 3368681
Temperature intolerance 78.90 22.42 23 5984 1028 3378824
Hyponatraemia 76.37 22.42 52 5955 18307 3361545
Malabsorption 76.11 22.42 26 5981 1955 3377897
Asphyxia 74.67 22.42 24 5983 1492 3378360
Premature baby 74.54 22.42 37 5970 7216 3372636
Psychomotor hyperactivity 74.36 22.42 29 5978 3178 3376674
Gastrooesophageal reflux disease 73.44 22.42 43 5964 11648 3368204
Loss of consciousness 72.92 22.42 60 5947 28087 3351765
Drug level changed 72.84 22.42 16 5991 220 3379632
Thyroxine abnormal 71.06 22.42 11 5996 13 3379839
Decreased appetite 69.16 22.42 69 5938 41421 3338431
Balance disorder 68.40 22.42 42 5965 12397 3367455
Oral discomfort 67.63 22.42 22 5985 1421 3378431
Basedow's disease 67.03 22.42 18 5989 593 3379259
Death 66.91 22.42 133 5874 152191 3227661
Loss of personal independence in daily activities 66.64 22.42 31 5976 5239 3374613
Agitation 66.20 22.42 49 5958 19657 3360195
Confusional state 64.81 22.42 64 5943 37934 3341918
Abdominal pain upper 64.29 22.42 53 5954 24863 3354989
Intentional product misuse 62.58 22.42 40 5967 12661 3367191
Hepatic enzyme increased 62.44 22.42 41 5966 13584 3366268
Adrenal insufficiency 61.46 22.42 22 5985 1899 3377953
Renal failure 60.90 22.42 58 5949 32882 3346970
Laboratory test abnormal 60.60 22.42 30 5977 5814 3374038
Medication error 60.01 22.42 38 5969 11833 3368019
Accidental exposure to product 60.01 22.42 28 5979 4764 3375088
Thyrotoxic crisis 59.85 22.42 13 5994 169 3379683
Arteriosclerosis coronary artery 59.51 22.42 24 5983 2870 3376982
Swelling face 58.85 22.42 37 5970 11379 3368473
Depressed level of consciousness 58.71 22.42 37 5970 11428 3368424
Brain injury 57.99 22.42 20 5987 1547 3378305
Seizure 57.95 22.42 62 5945 40338 3339514
Tri-iodothyronine increased 57.83 22.42 11 5996 69 3379783
Acidosis 57.55 22.42 23 5984 2687 3377165
Product colour issue 57.37 22.42 14 5993 312 3379540
Reaction to excipient 57.17 22.42 15 5992 451 3379401
Tri-iodothyronine decreased 57.16 22.42 11 5996 74 3379778
Acute kidney injury 55.56 22.42 67 5940 49616 3330236
Migraine 55.52 22.42 34 5973 9982 3369870
Organ donor 55.37 22.42 8 5999 3 3379849
Dyspepsia 54.95 22.42 36 5971 11876 3367976
Treatment failure 54.64 22.42 29 5978 6495 3373357
Blood creatine phosphokinase increased 54.43 22.42 37 5970 12976 3366876
Thyroxine free decreased 54.23 22.42 11 5996 100 3379752
Thyroxine free increased 53.94 22.42 11 5996 103 3379749
Chest discomfort 53.65 22.42 41 5966 17244 3362608
Stevens-Johnson syndrome 53.62 22.42 29 5978 6743 3373109
Dry mouth 53.57 22.42 33 5974 9789 3370063
Polyuria 53.41 22.42 20 5987 1961 3377891
Orthostatic hypotension 52.66 22.42 26 5981 5010 3374842
Foetal growth restriction 50.87 22.42 19 5988 1850 3378002
Drug level fluctuating 50.74 22.42 12 5995 233 3379619
Product physical issue 50.49 22.42 17 5990 1222 3378630
Maternal drugs affecting foetus 50.23 22.42 23 5984 3748 3376104
Unevaluable event 49.57 22.42 35 5972 13041 3366811
Poisoning 49.34 22.42 25 5982 5087 3374765
Gastrointestinal disorder 48.89 22.42 32 5975 10537 3369315
Dysphonia 48.17 22.42 28 5979 7476 3372376
Memory impairment 47.60 22.42 36 5971 14902 3364950
General physical health deterioration 47.34 22.42 41 5966 20548 3359304
Dehydration 47.11 22.42 51 5956 33598 3346254
Pulseless electrical activity 45.75 22.42 17 5990 1631 3378221
Hyperlactacidaemia 45.74 22.42 13 5994 530 3379322
Electrocardiogram QRS complex prolonged 45.27 22.42 16 5991 1330 3378522
Spinal column stenosis 44.87 22.42 17 5990 1721 3378131
Autoimmune thyroiditis 44.14 22.42 13 5994 602 3379250
Hepatic failure 43.86 22.42 30 5977 10622 3369230
Generalised tonic-clonic seizure 43.80 22.42 27 5980 8015 3371837
Pain in extremity 43.39 22.42 59 5948 49153 3330699
Hypokalaemia 43.39 22.42 33 5974 13772 3366080
Caesarean section 43.29 22.42 22 5985 4504 3375348
Hot flush 42.95 22.42 26 5981 7475 3372377
Oedema peripheral 42.80 22.42 49 5958 34312 3345540
Product packaging confusion 42.69 22.42 10 5997 186 3379666
Hypoglycaemia 42.32 22.42 33 5974 14285 3365567
Osteoarthritis 42.10 22.42 26 5981 7744 3372108
Cerebrovascular accident 41.74 22.42 49 5958 35239 3344613
Intracranial pressure increased 40.02 22.42 15 5992 1474 3378378
Polydipsia 39.96 22.42 14 5993 1134 3378718
Milk-alkali syndrome 39.41 22.42 9 5998 149 3379703
Disturbance in attention 38.49 22.42 25 5982 8123 3371729
Swelling 37.98 22.42 35 5972 19009 3360843
Depressed mood 37.97 22.42 23 5984 6618 3373234
Obesity 37.83 22.42 16 5991 2156 3377696
Pharyngeal oedema 37.72 22.42 20 5987 4467 3375385
Gastric disorder 37.71 22.42 19 5988 3819 3376033
Joint swelling 37.26 22.42 33 5974 17024 3362828
Deafness 36.73 22.42 19 5988 4035 3375817
Anaemia 36.09 22.42 57 5950 54276 3325576
Arrhythmia 35.22 22.42 26 5981 10371 3369481
Low birth weight baby 34.85 22.42 14 5993 1656 3378196
Blister 34.54 22.42 24 5983 8710 3371142
Growth hormone deficiency 34.00 22.42 7 6000 69 3379783
Paraesthesia 33.82 22.42 39 5968 27509 3352343
Goitre 33.64 22.42 12 5995 1025 3378827
Rhabdomyolysis 33.50 22.42 30 5977 15699 3364153
Congenital hypothyroidism 33.38 22.42 7 6000 76 3379776
Product taste abnormal 33.00 22.42 11 5996 766 3379086
Coma 32.97 22.42 27 5980 12525 3367327
Nervous system disorder 32.88 22.42 19 5988 5014 3374838
Thyroid cancer 32.43 22.42 12 5995 1137 3378715
Therapy non-responder 32.12 22.42 25 5982 10784 3369068
Burning sensation 31.82 22.42 23 5984 8881 3370971
Hypernatraemia 31.80 22.42 13 5994 1609 3378243
Hypersomnia 31.77 22.42 16 5991 3213 3376639
Disorientation 31.46 22.42 24 5983 10055 3369797
International normalised ratio increased 31.37 22.42 28 5979 14587 3365265
Urinary tract infection 31.36 22.42 40 5967 31288 3348564
Sputum discoloured 31.27 22.42 12 5995 1257 3378595
Sluggishness 31.10 22.42 12 5995 1276 3378576
Pyrexia 30.95 22.42 67 5940 81048 3298804
Mood swings 30.89 22.42 18 5989 4824 3375028
Discomfort 30.74 22.42 20 5987 6516 3373336
Myopathy 30.59 22.42 15 5992 2844 3377008
Amnesia 30.14 22.42 24 5983 10702 3369150
Muscle tightness 30.07 22.42 14 5993 2367 3377485
Electrocardiogram QT prolonged 30.00 22.42 24 5983 10771 3369081
Alanine aminotransferase increased 29.91 22.42 34 5973 23606 3356246
Rash generalised 29.89 22.42 23 5984 9759 3370093
Intentional self-injury 29.75 22.42 18 5989 5167 3374685
Back pain 29.66 22.42 43 5964 37962 3341890
Abortion 29.49 22.42 10 5997 734 3379118
Heart rate decreased 29.45 22.42 18 5989 5260 3374592
Cold sweat 29.43 22.42 15 5992 3088 3376764
Onychoclasis 29.38 22.42 10 5997 743 3379109
Choking 29.33 22.42 13 5994 1962 3377890
Oedema 29.30 22.42 27 5980 14653 3365199
Hyperkalaemia 29.05 22.42 24 5983 11270 3368582
Tinnitus 28.81 22.42 20 5987 7245 3372607
Osteoporosis 28.52 22.42 17 5990 4748 3375104
Musculoskeletal stiffness 28.51 22.42 26 5981 13924 3365928
Heart rate irregular 28.46 22.42 15 5992 3309 3376543
Vertigo 28.43 22.42 24 5983 11608 3368244
Photosensitivity reaction 28.32 22.42 15 5992 3342 3376510
Stress 28.27 22.42 20 5987 7466 3372386
Sinus bradycardia 28.23 22.42 15 5992 3364 3376488
Hyperreflexia 28.21 22.42 11 5996 1203 3378649
Gastritis 28.20 22.42 19 5988 6558 3373294
Thyroxine free abnormal 28.15 22.42 5 6002 20 3379832
Delirium 28.03 22.42 22 5985 9606 3370246
Sleep apnoea syndrome 28.01 22.42 15 5992 3415 3376437
Rheumatoid arthritis 27.85 22.42 27 5980 15611 3364241
Drug abuse 27.78 22.42 29 5978 18301 3361551
Tri-iodothyronine abnormal 27.33 22.42 4 6003 2 3379850
Product formulation issue 27.32 22.42 8 5999 363 3379489
Foetal hypokinesia 26.76 22.42 7 6000 208 3379644
Exophthalmos 26.62 22.42 8 5999 397 3379455
Bone erosion 26.39 22.42 8 5999 409 3379443
Premature delivery 26.38 22.42 13 5994 2492 3377360
Metastases to the mediastinum 26.17 22.42 6 6001 101 3379751
Lactic acidosis 25.95 22.42 19 5988 7481 3372371
Throat tightness 25.63 22.42 16 5991 4852 3375000
Altered state of consciousness 25.57 22.42 17 5990 5741 3374111
Inhibitory drug interaction 25.45 22.42 8 5999 462 3379390
Neck pain 25.45 22.42 20 5987 8747 3371105
Abnormal behaviour 25.14 22.42 21 5986 10007 3369845
Blood glucose increased 24.99 22.42 28 5979 19127 3360725
Rash erythematous 24.93 22.42 19 5988 7943 3371909
Blood calcium decreased 24.92 22.42 13 5994 2807 3377045
Ear discomfort 24.86 22.42 10 5997 1187 3378665
Thyroid neoplasm 24.75 22.42 9 5998 812 3379040
Rash pruritic 24.67 22.42 20 5987 9144 3370708
Hair texture abnormal 24.59 22.42 8 5999 516 3379336
Product solubility abnormal 24.56 22.42 7 6000 288 3379564
Vision blurred 24.48 22.42 28 5979 19561 3360291
Rotator cuff repair 24.40 22.42 7 6000 295 3379557
Muscle fatigue 24.39 22.42 8 5999 530 3379322
Sepsis 24.34 22.42 36 5971 32337 3347515
Impaired work ability 24.29 22.42 12 5995 2312 3377540
Hypercalcaemia 24.12 22.42 14 5993 3723 3376129
Drug level increased 24.09 22.42 15 5992 4530 3375322
Hypoacusis 23.86 22.42 15 5992 4605 3375247
Ventricular septal defect 23.81 22.42 11 5996 1828 3378024
Dysarthria 23.79 22.42 20 5987 9614 3370238
Drug effect variable 23.74 22.42 6 6001 155 3379697
Anal incontinence 23.74 22.42 12 5995 2428 3377424
Diabetes mellitus 23.60 22.42 22 5985 12111 3367741
Adrenocortical insufficiency acute 23.50 22.42 7 6000 337 3379515
Accidental exposure to product by child 23.27 22.42 10 5997 1401 3378451
Wrong drug administered 23.10 22.42 12 5995 2569 3377283
Blood pressure decreased 22.98 22.42 23 5984 13813 3366039
Cognitive disorder 22.94 22.42 18 5989 7856 3371996
Vitamin B12 decreased 22.79 22.42 7 6000 374 3379478
Product measured potency issue 22.72 22.42 6 6001 185 3379667
Speech disorder 22.64 22.42 19 5988 9113 3370739
Panic attack 22.55 22.42 15 5992 5069 3374783
Drug level decreased 22.52 22.42 10 5997 1516 3378336
Lactose intolerance 22.46 22.42 7 6000 393 3379459
Muscle spasticity 22.44 22.42 12 5995 2724 3377128

Pharmacologic Action:

SourceCodeDescription
ATC H03AA01 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
THYROID THERAPY
THYROID PREPARATIONS
Thyroid hormones
FDA EPC N0000175945 l-Thyroxine
FDA Chemical/Ingredient N0000007632 Thyroxine

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Goiter indication 3716002 DOID:12176
Hashimoto thyroiditis indication 21983002 DOID:7188
Hypothyroidism indication 40930008 DOID:1459
Myxedema indication 43153006 DOID:11634
Hyperlipidemia indication 55822004 DOID:1168
Congenital hypothyroidism indication 190268003
Malignant tumor of thyroid gland indication 363478007 DOID:1781
Diagnostic Test for Thyroid Dysfunction indication
Myxedema coma off-label use 21263006
Myocardial infarction contraindication 22298006 DOID:5844
Thyrotoxic crisis contraindication 29028009 DOID:12837
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Angina pectoris contraindication 194828000
Osteopenia contraindication 312894000
Primary adrenocortical insufficiency contraindication 373662000 DOID:13774
Disorder of coronary artery contraindication 414024009

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.08 acidic
pKa2 6.63 acidic
pKa3 8.6 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** LEVOXYL KING PHARMS N021301 May 25, 2001 DISCN TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thyroid hormone receptor beta Nuclear hormone receptor AGONIST IC50 8.52 IUPHAR CHEMBL
Thyroid hormone receptor alpha Nuclear hormone receptor AGONIST UNKNOWN IUPHAR
THAP domain-containing protein 1 Unclassified WOMBAT-PK
Transthyretin Secreted IC50 4.98 CHEMBL
Bile acid receptor Nuclear hormone receptor IC50 5.10 CHEMBL
Thyroid hormone receptor beta Transcription factor IC50 7.46 CHEMBL

External reference:

IDSource
DB00451 DRUGBANK_ID
2635 IUPHAR_LIGAND_ID
4017826 VUID
N0000179290 NUI
C0079691 UMLSCUI
D01010 KEGG_DRUG
CHEMBL559 ChEMBL_ID
054I36CPMN UNII
453 INN_ID
55-03-8 SECONDARY_CAS_RN
CHEMBL42115 ChEMBL_ID
4022126 VANDF
N0000007632 NDFRT
N0000020132 NDFRT
73187006 SNOMEDCT_US
d00278 MMSL
38076006 SNOMEDCT_US
005896 NDDF
710809001 SNOMEDCT_US
10582 RXNORM
004881 NDDF
CHEMBL1624 ChEMBL_ID
CHEMBL2103741 ChEMBL_ID
5819 PUBCHEM_CID
D013974 MESH_DESCRIPTOR_UI
CHEBI:6446 CHEBI
T44 PDB_CHEM_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1341 TABLET 0.03 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1342 TABLET 0.05 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1343 TABLET 0.08 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1344 TABLET 0.09 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1345 TABLET 0.10 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1346 TABLET 0.11 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1347 TABLET 0.13 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1349 TABLET 0.15 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1350 TABLET 0.18 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1351 TABLET 0.20 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1352 TABLET 0.30 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1370 TABLET 0.03 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1371 TABLET 0.05 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1372 TABLET 0.08 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1373 TABLET 0.09 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1374 TABLET 0.10 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1375 TABLET 0.11 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1376 TABLET 0.13 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1377 TABLET 0.15 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1378 TABLET 0.18 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1379 TABLET 0.20 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1380 TABLET 0.30 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1638 TABLET 0.14 mg ORAL NDA 11 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1639 TABLET 0.14 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-302 TABLET 0.10 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-403 TABLET 0.05 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-977 TABLET 0.11 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-748 TABLET 0.03 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-749 TABLET 0.05 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-750 TABLET 0.08 mg ORAL NDA 10 sections