naltrexone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists related to normorphine 1765 16590-41-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • naltrexone
  • cyclopropylmethylnoroxymorphone
  • naltrel
  • naltrexone hydrochloride
  • naltrexone hydrochloride dihydrate
  • naltrexone HCl
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.
  • Molecular weight: 341.41
  • Formula: C20H23NO4
  • CLOGP: 0.36
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 70
  • ALOGS: -2.05
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 100 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.44 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 22 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 7.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.79 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 1984 FDA TEVA WOMENS

FDA Adverse Event Reporting System (Female)

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
Injection site reaction 3314.27 19.26 1126 22638 50040 53275262
Alcoholism 2573.05 19.26 493 23271 1738 53323564
Injection site mass 2473.19 19.26 690 23074 15524 53309778
Injection site pain 1239.75 19.26 715 23049 112676 53212626
Injection site induration 916.68 19.26 278 23486 8380 53316922
Drug dependence 537.65 19.26 238 23526 21234 53304068
Therapeutic response shortened 445.42 19.26 153 23611 6886 53318416
Feeling abnormal 361.91 19.26 369 23395 134932 53190370
Product administered at inappropriate site 280.75 19.26 85 23679 2537 53322765
Withdrawal syndrome 254.01 19.26 138 23626 19163 53306139
Injection site swelling 222.11 19.26 170 23594 42458 53282844
Injection site abscess 201.41 19.26 54 23710 1027 53324275
Inappropriate schedule of product administration 195.78 19.26 202 23562 74676 53250626
Nausea 179.59 19.26 736 23028 755355 52569947
Anxiety 138.41 19.26 284 23480 196420 53128882
Inadequate analgesia 137.90 19.26 51 23713 2844 53322458
Drug use disorder 136.21 19.26 52 23712 3167 53322135
Insomnia 129.12 19.26 268 23496 186804 53138498
Injection site warmth 127.27 19.26 79 23685 14049 53311253
Product dose omission issue 123.55 19.26 267 23497 191353 53133949
Needle issue 120.52 19.26 60 23704 6952 53318350
Alcohol use 115.77 19.26 41 23723 2017 53323285
Drug screen positive 113.42 19.26 48 23716 3824 53321478
Injection site nodule 111.84 19.26 46 23718 3411 53321891
Lack of injection site rotation 95.94 19.26 23 23741 272 53325030
Substance abuse 94.01 19.26 44 23720 4450 53320852
Tremor 88.83 19.26 182 23582 125554 53199748
Alcohol poisoning 85.62 19.26 32 23732 1837 53323465
Headache 85.14 19.26 466 23298 536355 52788947
Rheumatoid arthritis 83.45 19.26 19 23745 314512 53010790
Product administration error 80.80 19.26 71 23693 21460 53303842
Depression 80.30 19.26 220 23544 182832 53142470
Body tinea 79.43 19.26 27 23737 1174 53324128
Lack of administration site rotation 77.93 19.26 12 23752 3 53325299
Pneumonia 76.88 19.26 43 23721 407126 52918176
Injection site pruritus 74.08 19.26 92 23672 41497 53283805
Euphoric mood 72.68 19.26 37 23727 4492 53320810
Acute kidney injury 72.17 19.26 13 23751 253855 53071447
Injection site erythema 70.83 19.26 125 23639 77124 53248178
Inhibitory drug interaction 69.11 19.26 29 23735 2261 53323041
Injection site discomfort 66.66 19.26 33 23731 3775 53321527
Dependence 64.24 19.26 27 23737 2114 53323188
Dizziness 64.19 19.26 331 23433 371928 52953374
Anaemia 63.57 19.26 22 23742 276696 53048606
Injection site cellulitis 63.28 19.26 23 23741 1220 53324082
Injection site cyst 62.36 19.26 12 23752 43 53325259
Drug titration error 60.42 19.26 19 23745 644 53324658
Infection susceptibility increased 59.83 19.26 27 23737 2510 53322792
Necrosis ischaemic 59.52 19.26 20 23744 839 53324463
Irritability 57.58 19.26 70 23694 30883 53294419
Injection site infection 52.73 19.26 22 23742 1691 53323611
Alcohol abuse 51.98 19.26 23 23741 2041 53323261
Feeling drunk 50.61 19.26 28 23736 4021 53321281
Hypotension 50.59 19.26 25 23739 254051 53071251
Imprisonment 49.90 19.26 13 23751 220 53325082
Impaired work ability 47.99 19.26 44 23720 14046 53311256
Food craving 47.73 19.26 20 23744 1554 53323748
Poor quality sleep 47.49 19.26 48 23716 17275 53308027
Dyspnoea 46.70 19.26 122 23642 586110 52739192
Glucose tolerance impaired 46.02 19.26 29 23735 5291 53320011
Pneumonia streptococcal 45.54 19.26 20 23744 1743 53323559
Neutropenia 45.54 19.26 8 23756 159177 53166125
Injection site bruising 45.43 19.26 69 23695 37577 53287725
Hospitalisation 44.54 19.26 98 23666 70914 53254388
Thrombocytopenia 44.29 19.26 5 23759 138722 53186580
Magnesium deficiency 43.79 19.26 14 23750 501 53324801
Feeling jittery 43.64 19.26 39 23725 12044 53313258
Impaired quality of life 43.26 19.26 27 23737 4844 53320458
General physical health deterioration 42.88 19.26 7 23757 146935 53178367
Beta haemolytic streptococcal infection 42.87 19.26 20 23744 2007 53323295
Drug intolerance 42.77 19.26 19 23745 205474 53119828
Systemic lupus erythematosus 41.38 19.26 4 23760 125410 53199892
Pregnancy 41.35 19.26 60 23704 31381 53293921
Crying 40.84 19.26 50 23714 22212 53303090
Alcohol withdrawal syndrome 40.80 19.26 15 23749 822 53324480
Panic attack 40.75 19.26 49 23715 21369 53303933
Surgery 40.59 19.26 60 23704 31904 53293398
Treatment failure 40.07 19.26 5 23759 128398 53196904
Injection site necrosis 39.99 19.26 17 23747 1369 53323933
Pyrexia 39.34 19.26 75 23689 403118 52922184
Illness 39.00 19.26 49 23715 22347 53302955
Wrong technique in product usage process 38.96 19.26 84 23680 59948 53265354
Suicidal ideation 37.37 19.26 83 23681 60428 53264874
Haemoglobin decreased 36.95 19.26 8 23756 137299 53188003
Platelet count decreased 36.87 19.26 3 23761 108096 53217206
Condition aggravated 36.85 19.26 47 23717 297087 53028215
Malabsorption from injection site 36.84 19.26 7 23757 23 53325279
Oedema peripheral 36.80 19.26 15 23749 170772 53154530
Somnolence 36.71 19.26 160 23604 167574 53157728
Apathy 36.48 19.26 30 23734 8282 53317020
Malaise 35.28 19.26 276 23488 357341 52967961
Detoxification 34.81 19.26 6 23758 9 53325293
Drug withdrawal syndrome 33.30 19.26 51 23713 27971 53297331
Atrial fibrillation 33.29 19.26 5 23759 111647 53213655
Infusion related reaction 33.11 19.26 14 23750 155943 53169359
Sepsis 32.97 19.26 12 23752 146417 53178885
Cough 32.51 19.26 40 23724 256853 53068449
Toothache 32.48 19.26 40 23724 17874 53307428
Fatigue 32.11 19.26 479 23285 730027 52595275
Abnormal dreams 32.07 19.26 31 23733 10570 53314732
Cold sweat 31.39 19.26 32 23732 11630 53313672
Feeling of despair 30.77 19.26 16 23748 2029 53323273
Death 30.19 19.26 72 23692 357160 52968142
Mood altered 30.11 19.26 34 23730 13867 53311435
Disease progression 29.40 19.26 5 23759 101915 53223387
Restless legs syndrome 28.90 19.26 37 23727 17186 53308116
Cardiac arrest 28.37 19.26 4 23760 93663 53231639
White blood cell count decreased 28.36 19.26 10 23754 124465 53200837
Pulmonary embolism 28.20 19.26 8 23756 114434 53210868
Restlessness 27.74 19.26 47 23717 28040 53297262
Hypersomnia 27.23 19.26 35 23729 16320 53308982
Aspartate aminotransferase increased 26.88 19.26 3 23761 84026 53241276
Caffeine consumption 26.87 19.26 4 23760 0 53325302
Exposure during pregnancy 26.83 19.26 11 23753 124849 53200453
Alanine aminotransferase increased 26.71 19.26 5 23759 95090 53230212
Fall 26.66 19.26 77 23687 358363 52966939
Nervousness 26.56 19.26 48 23716 30130 53295172
Death of relative 26.28 19.26 8 23756 243 53325059
Renal failure 26.17 19.26 10 23754 118442 53206860
Migraine 26.08 19.26 87 23677 80330 53244972
Product use issue 25.90 19.26 15 23749 139569 53185733
Mass 25.78 19.26 30 23734 12639 53312663
Drug screen false positive 25.68 19.26 11 23753 902 53324400
Hyperammonaemia 25.61 19.26 20 23744 5129 53320173
Bone density decreased 25.58 19.26 28 23736 11036 53314266
Adiposis dolorosa 25.47 19.26 8 23756 270 53325032
Anger 24.64 19.26 29 23735 12361 53312941
Purpura 24.29 19.26 27 23737 10826 53314476
Hyponatraemia 24.28 19.26 9 23755 108598 53216704
Road traffic accident 24.14 19.26 42 23722 25589 53299713
Blood creatinine increased 23.97 19.26 4 23760 82658 53242644
Arthropathy 23.78 19.26 17 23747 141436 53183866
Injection site irritation 23.62 19.26 18 23746 4454 53320848
Oral herpes 23.01 19.26 37 23727 21142 53304160
Rash 22.67 19.26 112 23652 446079 52879223
Dental operation 22.34 19.26 11 23753 1243 53324059
Urinary tract infection 22.17 19.26 46 23718 239857 53085445
Depressed mood 22.03 19.26 50 23714 36914 53288388
Snoring 21.67 19.26 16 23748 3776 53321526
Hyperhidrosis 21.66 19.26 93 23671 96700 53228602
Wound 21.47 19.26 7 23757 91550 53233752
Product preparation error 21.44 19.26 17 23747 4458 53320844
Yawning 21.18 19.26 10 23754 1031 53324271
Intentional overdose 21.16 19.26 72 23692 67133 53258169
Gastrointestinal haemorrhage 20.96 19.26 5 23759 80325 53244977
Renal impairment 20.20 19.26 6 23758 83312 53241990
Injection site haematoma 20.19 19.26 19 23745 6266 53319036
Decreased appetite 20.10 19.26 164 23600 214810 53110492
Joint swelling 20.03 19.26 47 23717 234591 53090711
Product preparation issue 19.99 19.26 8 23756 552 53324750
Patient dissatisfaction with treatment 19.95 19.26 5 23759 72 53325230
Disturbance in attention 19.93 19.26 46 23718 34337 53290965
Diaphragmatic paralysis 19.70 19.26 8 23756 574 53324728
Coronavirus infection 19.65 19.26 14 23750 3126 53322176
Mood swings 19.62 19.26 31 23733 17455 53307847

FDA Adverse Event Reporting System (Male)

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
Injection site reaction 5057.27 27.73 1226 19997 10343 32481960
Alcoholism 2903.55 27.73 629 20594 2943 32489360
Injection site pain 2768.40 27.73 971 20252 32087 32460216
Injection site mass 1398.44 27.73 380 20843 5121 32487182
Drug dependence 923.53 27.73 400 20823 23084 32469219
Feeling abnormal 652.40 27.73 435 20788 59988 32432315
Therapeutic response shortened 609.46 27.73 193 21030 4527 32487776
Injection site induration 587.34 27.73 165 21058 2519 32489784
Product administered at inappropriate site 395.38 27.73 111 21112 1688 32490615
Injection site swelling 371.99 27.73 162 21061 9422 32482881
Withdrawal syndrome 350.78 27.73 167 21056 11955 32480348
Needle issue 312.28 27.73 115 21108 4294 32488009
Product dose omission issue 309.47 27.73 357 20866 102218 32390085
Insomnia 264.28 27.73 326 20897 100022 32392281
Drug use disorder 251.09 27.73 93 21130 3528 32488775
Alcohol use 195.27 27.73 76 21147 3307 32488996
Inappropriate schedule of product administration 193.64 27.73 191 21032 45634 32446669
Injection site discomfort 193.28 27.73 59 21164 1217 32491086
Lack of injection site rotation 191.88 27.73 37 21186 80 32492223
Depression 160.13 27.73 252 20971 96808 32395495
Pain 159.76 27.73 367 20856 187189 32305114
Drug screen positive 155.77 27.73 69 21154 4172 32488131
Acute kidney injury 141.68 27.73 14 21209 293454 32198849
Anxiety 136.33 27.73 233 20990 95772 32396531
Substance abuse 119.31 27.73 68 21155 7039 32485264
Product administration error 116.33 27.73 90 21133 15535 32476768
Headache 114.28 27.73 333 20890 195864 32296439
Alcohol poisoning 112.76 27.73 51 21172 3238 32489065
Nausea 112.08 27.73 459 20764 320390 32171913
Injection site abscess 110.03 27.73 34 21189 731 32491572
Euphoric mood 109.81 27.73 58 21165 5169 32487134
Malaise 107.31 27.73 305 20918 176833 32315470
Pneumonia 101.42 27.73 53 21170 355199 32137104
Dependence 101.09 27.73 36 21187 1217 32491086
Imprisonment 100.73 27.73 29 21194 484 32491819
Drug withdrawal syndrome 99.94 27.73 92 21131 20139 32472164
Anaemia 99.56 27.73 14 21209 223610 32268693
Apathy 91.11 27.73 56 21167 6659 32485644
Irritability 89.91 27.73 95 21128 24559 32467744
Inadequate analgesia 81.39 27.73 39 21184 2824 32489479
Feeling drunk 79.79 27.73 34 21189 1869 32490434
Yawning 75.65 27.73 24 21199 564 32491739
Injection site erythema 74.96 27.73 68 21155 14600 32477703
Injection site bruising 73.86 27.73 52 21171 7768 32484535
Injection site nerve damage 70.51 27.73 12 21211 7 32492296
Lack of administration site rotation 67.04 27.73 11 21212 3 32492300
Injection site warmth 66.52 27.73 30 21193 1891 32490412
Decreased appetite 64.71 27.73 241 20982 160572 32331731
Road traffic accident 61.63 27.73 66 21157 17315 32474988
Renal failure 60.77 27.73 8 21215 134470 32357833
Tremor 60.22 27.73 151 21072 81126 32411177
Injection site nodule 59.39 27.73 26 21197 1527 32490776
Emotional poverty 59.28 27.73 19 21204 462 32491841
Fatigue 58.06 27.73 409 20814 350292 32142011
Sepsis 57.96 27.73 16 21207 158818 32333485
Toxicity to various agents 57.81 27.73 22 21201 178019 32314284
Hypotension 57.55 27.73 35 21188 216075 32276228
Thrombocytopenia 55.89 27.73 14 21209 148285 32344018
Feeling of despair 55.63 27.73 22 21201 998 32491305
Dyspnoea 55.22 27.73 95 21128 361950 32130353
Atrial fibrillation 55.05 27.73 6 21217 116698 32375605
Alcohol withdrawal syndrome 53.91 27.73 24 21199 1467 32490836
Pyrexia 53.45 27.73 79 21144 319889 32172414
Depressed mood 52.11 27.73 62 21161 18238 32474065
Platelet count decreased 51.33 27.73 7 21216 114584 32377719
Neutropenia 50.61 27.73 15 21208 142160 32350143
Haemoglobin decreased 49.78 27.73 9 21214 119662 32372641
Respiratory failure 46.94 27.73 7 21216 107175 32385128
Condition aggravated 46.10 27.73 22 21201 155639 32336664
Anger 45.40 27.73 47 21176 11857 32480446
Injection site pruritus 45.13 27.73 35 21188 6055 32486248
Disease progression 44.95 27.73 3 21220 86859 32405444
Pancytopenia 44.82 27.73 4 21219 91231 32401072
Mood altered 43.00 27.73 40 21183 8864 32483439
Blood creatinine increased 42.74 27.73 6 21217 96126 32396177
Oedema peripheral 42.53 27.73 11 21212 114080 32378223
Injection site cellulitis 42.09 27.73 15 21208 508 32491795
Gait disturbance 41.45 27.73 131 21092 80277 32412026
Restlessness 41.44 27.73 65 21158 24816 32467487
Substance use disorder 41.15 27.73 12 21211 210 32492093
Cardiac failure congestive 40.94 27.73 4 21219 84848 32407455
Hospitalisation 40.54 27.73 95 21128 48876 32443427
Overdose 40.52 27.73 137 21086 86940 32405363
Toothache 40.31 27.73 33 21190 6168 32486135
Cardiac failure 40.11 27.73 6 21217 91667 32400636
Hypersomnia 39.92 27.73 44 21179 11917 32480386
General physical health deterioration 39.50 27.73 13 21210 115246 32377057
Alcohol abuse 38.24 27.73 28 21195 4444 32487859
Substance use 37.78 27.73 14 21209 531 32491772
Hangover 37.54 27.73 17 21206 1082 32491221
Injection site inflammation 37.08 27.73 15 21208 722 32491581
Abdominal pain upper 36.82 27.73 112 21111 67226 32425077
Coronavirus infection 35.78 27.73 25 21198 3687 32488616
White blood cell count decreased 35.54 27.73 8 21215 91190 32401113
Myocardial infarction 35.34 27.73 19 21204 125657 32366646
Sciatic nerve injury 35.05 27.73 9 21214 95 32492208
Death of relative 34.91 27.73 7 21216 20 32492283
Wrong technique in product usage process 34.62 27.73 73 21150 34986 32457317
Mood swings 34.35 27.73 34 21189 8131 32484172
Product preparation error 34.20 27.73 19 21204 1871 32490432
Panic attack 32.53 27.73 35 21188 9226 32483077
Energy increased 31.44 27.73 16 21207 1319 32490984
Hyperhidrosis 31.37 27.73 110 21113 71058 32421245
Urinary tract infection 31.24 27.73 7 21216 80064 32412239
Thinking abnormal 30.51 27.73 27 21196 5608 32486695
Injection site infection 30.50 27.73 14 21209 919 32491384
Libido decreased 30.44 27.73 25 21198 4693 32487610
Muscle spasms 30.32 27.73 108 21115 70310 32421993
Feeling jittery 29.67 27.73 23 21200 3976 32488327
Product use in unapproved indication 29.58 27.73 10 21213 87194 32405109
Emotional disorder 29.32 27.73 26 21197 5415 32486888
Mobility decreased 29.04 27.73 60 21163 28349 32463954
Chromaturia 28.64 27.73 41 21182 14437 32477866
Bradycardia 28.44 27.73 6 21217 71556 32420747
Suicidal ideation 28.42 27.73 71 21152 38012 32454291
Surgery 28.41 27.73 38 21185 12561 32479742
Migraine 28.25 27.73 40 21183 13945 32478358
Drug interaction 28.18 27.73 63 21160 218122 32274181
Alcoholic hangover 27.74 27.73 5 21218 6 32492297

Pharmacologic Action:

SourceCodeDescription
ATC A08AA62 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
ATC N02AA56 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Natural opium alkaloids
ATC N07BB04 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in alcohol dependence
FDA MoA N0000000154 Opioid Antagonists
MeSH PA D000427 Alcohol Deterrents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D009292 Narcotic Antagonists
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35488 CNS depressants
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50137 mu-opioid receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:90755 antidote to opioid overdose
FDA EPC N0000175691 Opioid Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Alcoholism indication 7200002
Severe pain indication 76948002
Chronic pain indication 82423001
Obesity indication 414916001 DOID:9970
Prevention of opioid abuse indication 426928008
Therapeutic opioid induced constipation indication 136801000119102
Severe Pain with Opioid Tolerance indication
Chronic Pain with Opioid Tolerance indication
Neuropathic pain off-label use 247398009
Suicidal thoughts contraindication 6471006
Alcohol withdrawal delirium contraindication 8635005
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Chronic disease of respiratory system contraindication 17097001
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Low blood pressure contraindication 45007003
Gastrointestinal perforation contraindication 51875005
Paralytic ileus contraindication 55525008 DOID:8442
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Opioid dependence contraindication 75544000 DOID:2559
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Opioid withdrawal contraindication 87132004
Disorder of biliary tract contraindication 105997008 DOID:9741
Gastrointestinal obstruction contraindication 126765001
Seizure disorder contraindication 128613002
Drug-induced psychosis contraindication 191483003 DOID:1742
Acute hepatic failure contraindication 197270009
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Benign prostatic hyperplasia contraindication 266569009
Primary malignant neoplasm of gastrointestinal tract contraindication 363745004
Macrocolon contraindication 367495003
Eosinophilic asthma contraindication 367542003 DOID:9498
Primary adrenocortical insufficiency contraindication 373662000
Severe diarrhea contraindication 409587002
Central nervous system depression contraindication 418072004
Acute exacerbation of asthma contraindication 708038006
Increased Creatine Phosphokinase contraindication
Pain in Opioid Naive Patients contraindication
Opioid Use Within Last 4 Hours in Narcotic-Dependent Patient contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.31 acidic
pKa2 7.66 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 7462626 July 20, 2024 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8815889 July 20, 2024 FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
1.2MG;10MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
2.4MG;20MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
3.6MG;30MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
4.8MG;40MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
7.2MG;60MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
9.6MG;80MG TROXYCA ER PFIZER N207621 Aug. 19, 2016 DISCN CAPSULE, EXTENDED RELEASE ORAL 8685443 July 3, 2025 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9107837 June 4, 2027 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 7682633 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8158156 June 19, 2027 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10307376 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8318788 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8722085 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9125868 Nov. 8, 2027 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
380MG/VIAL VIVITROL ALKERMES N021897 April 13, 2006 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 7919499 Oct. 15, 2029 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
380MG/VIAL VIVITROL ALKERMES N021897 April 13, 2006 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 7919499 Oct. 15, 2029 TREATMENT OF ALCOHOL DEPENDENCE
100MG;4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
20MG;0.8MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
30MG;1.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
50MG;2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
60MG;2.4MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
80MG;3.2MG EMBEDA ALPHARMA PHARMS N022321 Aug. 13, 2009 DISCN CAPSULE, EXTENDED RELEASE ORAL 8623418 Nov. 7, 2029 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 8916195 Feb. 2, 2030 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11033543 Jan. 10, 2031 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9248123 Jan. 13, 2032 USE OF NALTREXONE AND BUPROPION FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10403170 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 11139056 June 5, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 9633575 June 25, 2033 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10231964 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10828294 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
90MG;8MG CONTRAVE NALPROPION N200063 Sept. 10, 2014 RX TABLET, EXTENDED RELEASE ORAL 10835527 July 2, 2034 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Delta-type opioid receptor GPCR ANTAGONIST Ki 7.99 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR ANTAGONIST Ki 8.93 WOMBAT-PK CHEMBL
Mu-type opioid receptor GPCR ANTAGONIST Ki 9.38 WOMBAT-PK CHEMBL
Cytochrome P450 2D6 Enzyme IC50 6 DRUG MATRIX
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.60 CHEMBL
Mu-type opioid receptor GPCR Ki 9.34 CHEMBL
Mu-type opioid receptor GPCR Ki 9.58 CHEMBL
Mu-type opioid receptor GPCR Ki 9.77 CHEMBL
Delta-type opioid receptor GPCR Ki 7.91 CHEMBL
Delta-type opioid receptor GPCR Ki 8.32 CHEMBL
Kappa-type opioid receptor GPCR Ki 9.51 CHEMBL
Neuronal acetylcholine receptor subunit alpha-4 Ion channel IC50 4.51 CHEMBL
Kappa-type opioid receptor GPCR Ki 8.97 CHEMBL
Kappa-type opioid receptor GPCR Ki 8.84 CHEMBL
Opioid receptor GPCR Ki 9.26 CHEMBL
Opioid receptors; mu and delta GPCR Ki 9.06 CHEMBL

External reference:

IDSource
4019853 VUID
N0000147939 NUI
D02095 KEGG_DRUG
16676-29-2 SECONDARY_CAS_RN
4018545 VANDF
4019853 VANDF
C0027360 UMLSCUI
CHEBI:7465 CHEBI
CHEMBL19019 ChEMBL_ID
CHEMBL1201149 ChEMBL_ID
D009271 MESH_DESCRIPTOR_UI
DB00704 DRUGBANK_ID
1639 IUPHAR_LIGAND_ID
3368 INN_ID
5S6W795CQM UNII
5360515 PUBCHEM_CID
105069 RXNORM
11621 MMSL
20600 MMSL
5151 MMSL
d01406 MMSL
001615 NDDF
004662 NDDF
373546002 SNOMEDCT_US
64191009 SNOMEDCT_US
87617007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0406-1170 TABLET, FILM COATED 50 mg ORAL ANDA 15 sections
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7036 TABLET, FILM COATED 50 mg ORAL ANDA 22 sections
EMBEDA HUMAN PRESCRIPTION DRUG LABEL 2 16590-897 CAPSULE, EXTENDED RELEASE 0.80 mg ORAL NDA 14 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-081 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-632 TABLET, FILM COATED 50 mg ORAL ANDA 25 sections
ContraveExtended-Release HUMAN PRESCRIPTION DRUG LABEL 2 43063-772 TABLET, EXTENDED RELEASE 8 mg ORAL NDA 31 sections
NALTREXONE HYDROCHLORIDE Human Prescription Drug Label 1 47335-326 TABLET, FILM COATED 50 mg ORAL ANDA 22 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-2866 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
ContraveExtended-Release HUMAN PRESCRIPTION DRUG LABEL 2 50090-2945 TABLET, EXTENDED RELEASE 8 mg ORAL NDA 30 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3076 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
NALTREXONE HYDROCHLORIDE Human Prescription Drug Label 1 50090-3929 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-4925 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51224-206 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
ContraveExtended-Release HUMAN PRESCRIPTION DRUG LABEL 2 51267-890 TABLET, EXTENDED RELEASE 8 mg ORAL NDA 31 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53217-261 TABLET, FILM COATED 50 mg ORAL ANDA 25 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5574 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Addex-1000 HUMAN PRESCRIPTION DRUG LABEL 1 57377-010 PELLET, IMPLANTABLE 1000 mg SUBCUTANEOUS Export only 4 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 62135-242 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 63629-1046 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 63629-1047 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 68084-291 TABLET, FILM COATED 50 mg ORAL ANDA 16 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 68094-853 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Naltrexone HUMAN PRESCRIPTION DRUG LABEL 2 69364-3143 IMPLANT 200 mg SUBCUTANEOUS Unapproved drug other 25 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 70518-1146 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 70518-2718 TABLET, FILM COATED 50 mg ORAL ANDA 22 sections
Naltrexone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 71335-0014 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 71335-1480 TABLET, FILM COATED 50 mg ORAL ANDA 15 sections
NALTREXONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 76519-1160 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections