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

Stem definitionDrug idCAS RN
opioid receptor antagonists/agonists, morphinan derivates 434 52485-79-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • buprenorphine
  • buprenorfine
  • norspan
  • buprenorphine hydrochloride
  • buprenorphine HCl
A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
  • Molecular weight: 467.65
  • Formula: C29H41NO4
  • CLOGP: 3.99
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 62.16
  • ALOGS: -4.44
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.20 mg P
1.20 mg SL
1.20 mg TD
2.10 mg P
8 mg SL
8 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 17 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) 0.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 28 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 19 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 19, 2019 EMA L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
Dec. 29, 1981 FDA RECKITT BENCKISER

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
Drug withdrawal syndrome 1593.89 13.11 641 34190 26743 46624488
Application site pruritus 1553.40 13.11 398 34433 3615 46647616
Product adhesion issue 1470.18 13.11 398 34433 4557 46646674
Application site erythema 1071.24 13.11 310 34521 4594 46646637
Application site rash 829.72 13.11 221 34610 2361 46648870
Drug dependence 753.54 13.11 344 34487 19557 46631674
Application site pain 651.83 13.11 202 34629 3821 46647410
Application site vesicles 649.36 13.11 162 34669 1302 46649929
Inadequate analgesia 641.01 13.11 184 34647 2640 46648591
Maternal exposure during pregnancy 555.89 13.11 520 34311 102029 46549202
Application site burn 520.79 13.11 122 34709 726 46650505
Drug abuse 481.70 13.11 390 34441 63018 46588213
Drug withdrawal syndrome neonatal 430.29 13.11 124 34707 1804 46649427
Wrong technique in product usage process 367.93 13.11 313 34518 54109 46597122
Application site irritation 322.89 13.11 98 34733 1721 46649510
Product solubility abnormal 317.24 13.11 82 34749 770 46650461
Intentional underdose 293.54 13.11 92 34739 1806 46649425
Withdrawal syndrome 254.05 13.11 162 34669 17972 46633259
Substance abuse 253.81 13.11 101 34730 4066 46647165
Product preparation error 235.96 13.11 95 34736 3944 46647287
Product use issue 224.52 13.11 313 34518 94331 46556900
Exposure during pregnancy 217.67 13.11 331 34500 107881 46543350
Application site scar 209.83 13.11 46 34785 192 46651039
Application site discharge 208.96 13.11 43 34788 122 46651109
Drug screen negative 208.56 13.11 50 34781 333 46650898
Foetal exposure during pregnancy 203.86 13.11 175 34656 30572 46620659
Application site erosion 194.02 13.11 42 34789 163 46651068
Inappropriate schedule of product administration 192.79 13.11 240 34591 64773 46586458
Product substitution issue 175.82 13.11 120 34711 14911 46636320
Application site exfoliation 169.24 13.11 41 34790 287 46650944
Application site dryness 167.70 13.11 36 34795 133 46651098
Product dosage form issue 158.92 13.11 31 34800 60 46651171
Premature delivery 157.34 13.11 131 34700 21938 46629293
Application site discolouration 154.83 13.11 46 34785 748 46650483
Oral administration complication 127.31 13.11 28 34803 119 46651112
Abortion spontaneous 125.92 13.11 159 34672 43487 46607744
Hyperhidrosis 125.72 13.11 233 34598 89075 46562156
Euphoric mood 125.25 13.11 62 34769 4210 46647021
Application site urticaria 125.11 13.11 31 34800 241 46650990
Product physical issue 119.73 13.11 63 34768 4864 46646367
Nausea 110.49 13.11 881 33950 686573 45964658
Intentional product misuse 110.31 13.11 155 34676 46973 46604258
Oral mucosal blistering 109.25 13.11 59 34772 4801 46646430
Application site swelling 106.59 13.11 32 34799 540 46650691
Drug screen positive 103.88 13.11 53 34778 3838 46647393
Application site reaction 102.60 13.11 33 34798 706 46650525
Respiratory depression 100.02 13.11 77 34754 11523 46639708
Product packaging quantity issue 99.58 13.11 36 34795 1108 46650123
Drug use disorder 96.27 13.11 45 34786 2690 46648541
Accidental exposure to product by child 92.77 13.11 34 34797 1089 46650142
Product administered at inappropriate site 92.62 13.11 42 34789 2341 46648890
Maternal exposure during breast feeding 92.37 13.11 44 34787 2745 46648486
Vomiting 88.18 13.11 608 34223 452186 46199045
Overdose 87.86 13.11 218 34613 101761 46549470
Placental hypertrophy 86.82 13.11 14 34817 0 46651231
Rheumatoid arthritis 82.57 13.11 38 34793 240177 46411054
Toxicity to various agents 82.16 13.11 344 34487 211422 46439809
Jaundice neonatal 82.08 13.11 29 34802 834 46650397
Therapeutic product effect increased 80.72 13.11 30 34801 1000 46650231
Tongue blistering 77.31 13.11 32 34799 1426 46649805
Drug diversion 74.59 13.11 27 34804 834 46650397
Cough 73.74 13.11 40 34791 230209 46421022
Somnolence 70.91 13.11 267 34564 156254 46494977
Drug delivery system removal 68.22 13.11 11 34820 0 46651231
Product physical consistency issue 65.26 13.11 21 34810 450 46650781
Abortion induced 65.13 13.11 57 34774 10203 46641028
Placental disorder 64.97 13.11 28 34803 1381 46649850
Pyrexia 64.01 13.11 101 34730 348701 46302530
Diarrhoea 61.08 13.11 214 34617 559388 46091843
Application site scab 59.77 13.11 16 34815 174 46651057
Drug detoxification 58.48 13.11 16 34815 190 46651041
Product dispensing issue 58.32 13.11 12 34819 34 46651197
Alcohol abuse 56.28 13.11 29 34802 2143 46649088
Application site ulcer 55.60 13.11 14 34817 117 46651114
Fatigue 55.50 13.11 250 34581 608447 46042784
Neutropenia 55.14 13.11 19 34812 143185 46508046
Selective abortion 51.66 13.11 14 34817 160 46651071
Application site haemorrhage 50.79 13.11 21 34810 933 46650298
Nasopharyngitis 50.37 13.11 26 34805 153972 46497259
Injection site pain 50.33 13.11 185 34646 106967 46544264
Rhesus incompatibility 50.04 13.11 12 34819 80 46651151
Exposure via breast milk 49.93 13.11 23 34808 1329 46649902
Injection site infection 49.41 13.11 24 34807 1563 46649668
Application site dermatitis 48.60 13.11 14 34817 203 46651028
Hallucination 48.59 13.11 112 34719 49839 46601392
Sinusitis 46.96 13.11 19 34812 129749 46521482
Stress cardiomyopathy 46.93 13.11 42 34789 7742 46643489
Platelet count decreased 46.65 13.11 9 34822 100015 46551216
White blood cell count decreased 46.59 13.11 13 34818 112218 46539013
Miosis 46.36 13.11 39 34792 6618 46644613
Pneumonia 45.76 13.11 137 34694 376183 46275048
Anaemia 44.13 13.11 77 34754 255702 46395529
Haemoglobin decreased 43.33 13.11 21 34810 128928 46522303
Product formulation issue 43.31 13.11 17 34814 659 46650572
Febrile neutropenia 43.12 13.11 9 34822 94618 46556613
Disease progression 43.03 13.11 8 34823 91292 46559939
Yawning 43.03 13.11 18 34813 824 46650407
Thrombocytopenia 41.94 13.11 21 34810 126560 46524671
Bradycardia foetal 41.03 13.11 14 34817 362 46650869
Breakthrough pain 40.69 13.11 19 34812 1133 46650098
Device leakage 40.63 13.11 33 34798 5332 46645899
Injection site extravasation 39.70 13.11 36 34795 6749 46644482
Infusion related reaction 39.69 13.11 13 34818 101195 46550036
Arthralgia 39.28 13.11 140 34691 364463 46286768
Impaired reasoning 39.08 13.11 9 34822 49 46651182
Intentional product use issue 38.41 13.11 106 34725 52674 46598557
Subchondral insufficiency fracture 38.06 13.11 9 34822 56 46651175
Faecaloma 37.47 13.11 37 34794 7715 46643516
Injection site cellulitis 37.42 13.11 18 34813 1147 46650084
17 ketosteroids urine abnormal 37.21 13.11 6 34825 0 46651231
Disturbance in attention 36.64 13.11 76 34755 31484 46619747
Application site odour 36.18 13.11 8 34823 35 46651196
Poor feeding infant 35.77 13.11 11 34820 202 46651029
Respiratory arrest 35.31 13.11 78 34753 33738 46617493
Asthenia 35.14 13.11 117 34714 310958 46340273
Therapeutic product effect decreased 34.96 13.11 138 34693 82463 46568768
Application site induration 34.78 13.11 6 34825 3 46651228
Prescription drug used without a prescription 34.27 13.11 18 34813 1384 46649847
Suicidal ideation 33.17 13.11 105 34726 56277 46594954
Application site inflammation 32.90 13.11 12 34819 379 46650852
Dermatitis contact 32.45 13.11 35 34796 8088 46643143
Hyperaesthesia 31.65 13.11 34 34797 7822 46643409
Therapy naive 31.59 13.11 7 34824 31 46651200
Incorrect route of product administration 31.28 13.11 49 34782 16334 46634897
Stomatitis 31.27 13.11 117 34714 68180 46583051
Sedation 29.98 13.11 58 34773 22852 46628379
Feeling abnormal 29.74 13.11 177 34654 124883 46526348
Joint swelling 29.53 13.11 49 34782 166024 46485207
Alopecia 28.80 13.11 48 34783 162366 46488865
Application site bruise 28.65 13.11 10 34821 277 46650954
Contraindicated product administered 28.44 13.11 12 34819 79935 46571296
Systemic lupus erythematosus 28.09 13.11 7 34824 65173 46586058
Injection site abscess 27.81 13.11 14 34817 985 46650246
Tongue discomfort 27.70 13.11 17 34814 1760 46649471
Retching 27.68 13.11 41 34790 13016 46638215
Psoriasis 27.64 13.11 12 34819 78592 46572639
Application site papules 27.54 13.11 7 34824 61 46651170
Infection 27.07 13.11 36 34795 133556 46517675
Product colour issue 26.97 13.11 12 34819 639 46650592
Pain in extremity 26.71 13.11 101 34730 258579 46392652
Drug effect less than expected 26.50 13.11 7 34824 72 46651159
Foetal malformation 26.11 13.11 8 34823 145 46651086
Treatment failure 25.86 13.11 19 34812 93068 46558163
Foetal growth restriction 25.71 13.11 28 34803 6539 46644692
Extra dose administered 25.64 13.11 24 34807 4683 46646548
Premature baby 25.12 13.11 47 34784 18065 46633166
Dyspnoea 25.07 13.11 255 34576 515293 46135938
Glossitis 25.02 13.11 19 34812 2784 46648447
Oral discomfort 24.67 13.11 30 34801 7888 46643343
Monoplegia 24.45 13.11 18 34813 2518 46648713
Pancytopenia 24.10 13.11 17 34814 85041 46566190
Cataract 23.62 13.11 3 34828 45412 46605819
Swollen tongue 23.57 13.11 61 34770 29171 46622060
Judgement impaired 23.55 13.11 11 34820 656 46650575
Anxiety 23.55 13.11 223 34608 181734 46469497
Bronchitis 23.10 13.11 27 34804 105952 46545279
Foreign body reaction 22.96 13.11 6 34825 59 46651172
Pleural effusion 22.95 13.11 17 34814 82935 46568296
Product prescribing error 22.94 13.11 48 34783 19999 46631232
Interstitial lung disease 22.85 13.11 6 34825 53943 46597288
Unresponsive to stimuli 22.79 13.11 64 34767 32110 46619121
Eyelid retraction 22.78 13.11 6 34825 61 46651170
Migraine 22.72 13.11 108 34723 69918 46581313
Cardiac failure congestive 22.67 13.11 21 34810 91729 46559502
Tongue erythema 22.29 13.11 8 34823 241 46650990
Tooth hypoplasia 22.19 13.11 6 34825 68 46651163
Hypotension 21.99 13.11 94 34737 232495 46418736
Accidental overdose 21.76 13.11 47 34784 20019 46631212
Bruxism 21.68 13.11 18 34813 2999 46648232
Headache 21.52 13.11 487 34344 477865 46173366
Genitourinary symptom 21.29 13.11 6 34825 80 46651151
Maternal use of illicit drugs 21.15 13.11 4 34827 6 46651225
Spasmodic dysphonia 20.77 13.11 6 34825 88 46651143
Hypertension 20.69 13.11 76 34755 196280 46454951
Neurosis 20.51 13.11 8 34823 305 46650926
Restlessness 20.31 13.11 53 34778 25471 46625760
Leukopenia 20.24 13.11 13 34818 68330 46582901
Arthropathy 20.21 13.11 20 34811 84680 46566551
Feeling of body temperature change 20.00 13.11 20 34811 4232 46646999
Product contamination 19.28 13.11 9 34822 536 46650695
Dependence 19.28 13.11 14 34817 1917 46649314
Endocarditis staphylococcal 19.27 13.11 8 34823 359 46650872
Low birth weight baby 19.27 13.11 22 34809 5412 46645819
Injection site erosion 19.24 13.11 5 34826 48 46651183
Cardio-respiratory arrest 19.18 13.11 92 34739 59777 46591454
Maternal drugs affecting foetus 18.99 13.11 22 34809 5496 46645735
Injection site ulcer 18.97 13.11 9 34822 556 46650675
Atrial fibrillation 18.93 13.11 30 34801 103560 46547671
Neuropathy peripheral 18.91 13.11 24 34807 90869 46560362
Dyspnoea exertional 18.78 13.11 7 34824 50282 46600949
Pulmonary embolism 18.41 13.11 33 34798 108552 46542679
Application site infection 18.15 13.11 5 34826 61 46651170
Influenza 18.13 13.11 24 34807 89246 46561985
Neonatal aspiration 18.12 13.11 6 34825 141 46651090
Chest pain 18.08 13.11 69 34762 176255 46474976
Neutrophil count decreased 18.07 13.11 5 34826 43421 46607810
Insurance issue 18 13.11 13 34818 1765 46649466
Urinary tract infection 17.90 13.11 94 34737 220172 46431059
Dermatitis allergic 17.84 13.11 33 34798 12570 46638661
Product dose omission issue 17.24 13.11 66 34765 168454 46482777
Blood glucose increased 17.18 13.11 17 34814 71996 46579235
Confusional state 16.88 13.11 188 34643 159704 46491527
Application site pustules 16.77 13.11 4 34827 26 46651205
Hepatitis C 16.61 13.11 22 34809 6296 46644935
Chondrodystrophy 16.25 13.11 5 34826 92 46651139
Application site discomfort 16.19 13.11 7 34824 348 46650883
Tremor 16.09 13.11 144 34687 115495 46535736
Blood cholesterol increased 15.93 13.11 5 34826 40008 46611223
Premature rupture of membranes 15.84 13.11 18 34813 4405 46646826
Coronary artery disease 15.81 13.11 3 34828 33749 46617482
Focal segmental glomerulosclerosis 15.80 13.11 11 34820 1410 46649821
Gastrointestinal hypomotility 15.79 13.11 10 34821 1094 46650137
Substance dependence 15.60 13.11 6 34825 220 46651011
Accidental poisoning 15.45 13.11 8 34823 597 46650634
Myocardial infarction 15.34 13.11 31 34800 97497 46553734
Upper respiratory tract infection 15.17 13.11 15 34816 63541 46587690
Herpes zoster 15.10 13.11 17 34814 67855 46583376
Therapeutic response shortened 15.07 13.11 19 34812 5180 46646051
Application site laceration 15.00 13.11 3 34828 7 46651224
Malignant neoplasm progression 14.73 13.11 16 34815 64910 46586321
Product taste abnormal 14.71 13.11 12 34819 1951 46649280
Hypokalaemia 14.70 13.11 27 34804 87997 46563234
Drug level decreased 14.65 13.11 20 34811 5892 46645339
Hypoaesthesia 14.59 13.11 43 34788 118826 46532405
Productive cough 14.54 13.11 10 34821 50705 46600526
Withdrawal hypertension 14.41 13.11 5 34826 136 46651095
Gastrointestinal disorder 14.29 13.11 14 34817 59562 46591669
Lack of application site rotation 14.21 13.11 3 34828 10 46651221
Lack of administration site rotation 14.21 13.11 3 34828 10 46651221
Diabetes mellitus 14.19 13.11 10 34821 50055 46601176
Aspartate aminotransferase increased 14.18 13.11 23 34808 78677 46572554
Sepsis 14.09 13.11 53 34778 135961 46515270
Blood pressure increased 14.02 13.11 48 34783 126618 46524613
Mouth ulceration 14.01 13.11 48 34783 26784 46624447
Ascites 13.82 13.11 5 34826 36579 46614652
Dental discomfort 13.73 13.11 6 34825 306 46650925
Application site warmth 13.70 13.11 5 34826 158 46651073
Abdominal pain 13.66 13.11 108 34723 229923 46421308
Diverticulitis 13.38 13.11 4 34827 33035 46618196
Epistaxis 13.35 13.11 17 34814 64288 46586943
Tooth discolouration 13.25 13.11 8 34823 804 46650427
Dental caries 13.24 13.11 26 34805 10353 46640878
Urinary incontinence 13.15 13.11 49 34782 28481 46622750
Bone marrow failure 13.15 13.11 3 34828 29666 46621565
Blood creatinine increased 13.14 13.11 23 34808 76380 46574851

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
Drug withdrawal syndrome 2078.76 14.67 798 33327 19011 29899342
Drug abuse 1521.15 14.67 1019 33106 81053 29837300
Drug dependence 1517.29 14.67 650 33475 20645 29897708
Intentional product misuse 708.94 14.67 459 33666 34208 29884145
Product adhesion issue 508.79 14.67 146 33979 1319 29917034
Substance abuse 487.56 14.67 211 33914 6829 29911524
Drug withdrawal syndrome neonatal 469.34 14.67 165 33960 3010 29915343
Intentional product use issue 430.52 14.67 346 33779 36094 29882259
Toxicity to various agents 419.59 14.67 734 33391 176449 29741904
Injection site pain 417.05 14.67 315 33810 29995 29888358
Withdrawal syndrome 410.35 14.67 217 33908 11033 29907320
Drug use disorder 358.13 14.67 136 33989 3112 29915241
Overdose 353.67 14.67 457 33668 83880 29834473
Miosis 341.48 14.67 170 33955 7606 29910747
Application site pruritus 337.66 14.67 105 34020 1278 29917075
Intentional underdose 333.11 14.67 92 34033 712 29917641
Drug screen negative 295.57 14.67 67 34058 197 29918156
Alcohol abuse 286.37 14.67 134 33991 5219 29913134
Drug detoxification 265.30 14.67 60 34065 174 29918179
Product use issue 262.74 14.67 292 33833 45724 29872629
Application site rash 258.50 14.67 76 34049 753 29917600
Application site erythema 248.73 14.67 95 34030 2208 29916145
Product solubility abnormal 246.00 14.67 67 34058 489 29917864
Inadequate analgesia 244.14 14.67 98 34027 2610 29915743
Drug screen positive 231.65 14.67 109 34016 4298 29914055
Wrong technique in product usage process 228.39 14.67 226 33899 30929 29887424
Product substitution issue 214.90 14.67 137 33988 9898 29908455
Product preparation error 193.71 14.67 73 34052 1633 29916720
Euphoric mood 191.89 14.67 95 34030 4195 29914158
Respiratory depression 188.52 14.67 133 33992 11370 29906983
Foetal exposure during pregnancy 178.50 14.67 215 33910 36656 29881697
Application site burn 177.21 14.67 44 34081 211 29918142
Injection site infection 171.78 14.67 56 34069 801 29917552
Application site vesicles 165.92 14.67 50 34075 543 29917810
Inappropriate schedule of product administration 159.48 14.67 211 33914 39517 29878836
Injection site abscess 153.07 14.67 49 34076 659 29917694
Application site pain 142.38 14.67 58 34067 1605 29916748
Injection site ulcer 141.94 14.67 37 34088 223 29918130
Accidental exposure to product by child 135.49 14.67 55 34070 1508 29916845
Coma 129.82 14.67 193 33932 40256 29878097
Somnolence 124.47 14.67 313 33812 96450 29821903
Injection site erythema 121.56 14.67 111 34014 13723 29904630
Accidental overdose 114.68 14.67 122 34003 18153 29900200
Hyperhidrosis 112.59 14.67 241 33884 66849 29851504
Drug diversion 110.57 14.67 41 34084 875 29917478
Drug delivery system removal 109.80 14.67 19 34106 0 29918353
Pneumonia 102.63 14.67 139 33986 334167 29584186
Pyrexia 101.37 14.67 112 34013 294377 29623976
Maternal exposure during breast feeding 100.28 14.67 45 34080 1587 29916766
Injection site extravasation 99.21 14.67 49 34076 2151 29916202
Febrile neutropenia 94.77 14.67 7 34118 106686 29811667
Application site irritation 89.89 14.67 33 34092 684 29917669
Oral administration complication 85.35 14.67 20 34105 71 29918282
Injection site erosion 81.41 14.67 19 34106 66 29918287
Diarrhoea 77.57 14.67 166 33959 333937 29584416
Therapeutic product effect decreased 74.25 14.67 125 34000 28951 29889402
Nausea 74.02 14.67 584 33541 296373 29621980
Anaemia 73.79 14.67 77 34048 207915 29710438
Asphyxia 73.64 14.67 56 34069 5369 29912984
Atrial fibrillation 72.68 14.67 17 34108 108107 29810246
Hypotension 72.56 14.67 73 34052 200492 29717861
Cough 71.31 14.67 27 34098 125615 29792738
Jaundice neonatal 69.80 14.67 31 34094 1066 29917287
Platelet count decreased 66.90 14.67 19 34106 106110 29812243
Brain oedema 64.40 14.67 75 34050 12323 29906030
Brachial artery entrapment syndrome 63.57 14.67 11 34114 0 29918353
Prescription drug used without a prescription 62.59 14.67 30 34095 1232 29917121
Endocarditis 62.09 14.67 53 34072 5990 29912363
Product colour issue 61.66 14.67 22 34103 419 29917934
Application site reaction 61.51 14.67 22 34103 422 29917931
Application site dryness 61.30 14.67 14 34111 43 29918310
White blood cell count decreased 60.96 14.67 11 34114 83936 29834417
Injection site discharge 60.06 14.67 15 34110 74 29918279
Congenital multiplex arthrogryposis 59.31 14.67 13 34112 31 29918322
Cardiac failure congestive 59.30 14.67 12 34113 84395 29833958
Cluster headache 59.24 14.67 23 34102 559 29917794
Injection site vesicles 58.37 14.67 22 34103 492 29917861
Agitation 58.33 14.67 164 33961 53909 29864444
Injection site necrosis 56.19 14.67 20 34105 378 29917975
Therapeutic product effect increased 55.70 14.67 23 34102 659 29917694
Product dosage form issue 54.66 14.67 13 34112 50 29918303
Exposure via breast milk 53.55 14.67 29 34096 1543 29916810
Dermo-hypodermitis 53.35 14.67 18 34107 288 29918065
Oral mucosal blistering 52.98 14.67 30 34095 1743 29916610
Deafness neurosensory 52.03 14.67 33 34092 2360 29915993
Application site urticaria 51.58 14.67 13 34112 67 29918286
Anxiety 50.09 14.67 219 33906 89652 29828701
Neuropathy peripheral 49.53 14.67 10 34115 70465 29847888
Cerebrovascular accident 48.93 14.67 17 34108 83460 29834893
Tongue blistering 48.13 14.67 16 34109 244 29918109
Product taste abnormal 47.75 14.67 24 34101 1094 29917259
Application site swelling 46.80 14.67 16 34109 267 29918086
Intentional removal of drug delivery system by patient 46.23 14.67 8 34117 0 29918353
Haemoglobin decreased 45.38 14.67 38 34087 114060 29804293
Injection site cellulitis 44.73 14.67 18 34107 482 29917871
Hepatitis C 43.74 14.67 64 34061 13141 29905212
Neutropenia 42.85 14.67 50 34075 128490 29789863
Sedation 42.60 14.67 71 34054 16302 29902051
Disease progression 42.32 14.67 19 34106 79855 29838498
Application site discolouration 42.20 14.67 14 34111 212 29918141
Injection site warmth 42.07 14.67 26 34099 1776 29916577
Tremor neonatal 41.87 14.67 16 34109 372 29917981
Application site exfoliation 41.74 14.67 12 34113 109 29918244
Fatigue 41.69 14.67 206 33919 320467 29597886
Logorrhoea 41.05 14.67 27 34098 2055 29916298
Glomerulonephritis acute 41.03 14.67 11 34114 75 29918278
Low birth weight baby 40.66 14.67 42 34083 6034 29912319
Vomiting 40.46 14.67 405 33720 219413 29698940
Premature baby 40.28 14.67 70 34055 16621 29901732
Pleural effusion 40.21 14.67 17 34108 74049 29844304
Malignant neoplasm progression 40.21 14.67 16 34109 72271 29846082
Product formulation issue 40.10 14.67 17 34108 521 29917832
Application site scar 40.07 14.67 9 34116 25 29918328
Product dispensing issue 39.60 14.67 10 34115 52 29918301
Sarcopenia 39.56 14.67 14 34111 260 29918093
Blood creatinine increased 39.42 14.67 28 34097 91347 29827006
Feeling abnormal 39.31 14.67 148 33977 56608 29861745
Drug effect less than expected 39.29 14.67 10 34115 54 29918299
Product packaging quantity issue 39 14.67 18 34107 678 29917675
Poor feeding infant 38.58 14.67 15 34110 366 29917987
Injection site irritation 38.43 14.67 20 34105 981 29917372
Asthenia 38.26 14.67 127 33998 221163 29697190
Bradypnoea 38.09 14.67 25 34100 1896 29916457
Aggression 37.90 14.67 110 34015 36797 29881556
Accidental poisoning 37.82 14.67 16 34109 488 29917865
Aptyalism 37.64 14.67 13 34112 224 29918129
Interstitial lung disease 37.50 14.67 11 34114 60186 29858167
International normalised ratio increased 37.49 14.67 5 34120 47734 29870619
Dependence 37.32 14.67 21 34104 1205 29917148
Arthralgia 37.07 14.67 61 34064 135730 29782623
Acute kidney injury 36.67 14.67 174 33951 273668 29644685
Impaired driving ability 36.41 14.67 27 34098 2491 29915862
Drug abuser 36.11 14.67 34 34091 4367 29913986
Thrombocytopenia 36.09 14.67 63 34062 136981 29781372
Congestive hepatopathy 35.87 14.67 24 34101 1880 29916473
Dyspnoea 35.76 14.67 228 33897 333067 29585286
Housebound 35.74 14.67 12 34113 189 29918164
Application site erosion 35.58 14.67 10 34115 83 29918270
Renal failure 35.14 14.67 58 34067 128908 29789445
Dehydration 35.13 14.67 54 34071 123485 29794868
Epistaxis 34.27 14.67 9 34116 52972 29865381
Feeding intolerance 34.14 14.67 9 34116 57 29918296
Aspartate aminotransferase increased 33.72 14.67 15 34110 63407 29854946
Suicidal ideation 33.64 14.67 104 34021 36010 29882343
Blood glucose increased 33.60 14.67 14 34111 61516 29856837
Substance use disorder 33.48 14.67 10 34115 105 29918248
Injection site inflammation 33.47 14.67 16 34109 653 29917700
Restlessness 33.14 14.67 77 34048 22522 29895831
Coronary artery disease 33.01 14.67 8 34117 49704 29868649
Product physical issue 32.99 14.67 24 34101 2150 29916203
Purpura fulminans 32.82 14.67 10 34115 113 29918240
Prescription form tampering 32.75 14.67 15 34110 555 29917798
Infusion related reaction 32.45 14.67 4 34121 40560 29877793
Application site hypersensitivity 32.20 14.67 10 34115 121 29918232
Respiratory rate decreased 32.09 14.67 22 34103 1793 29916560
Hyperkalaemia 31.52 14.67 18 34107 65992 29852361
Application site discharge 31.34 14.67 10 34115 133 29918220
Endocarditis staphylococcal 31.27 14.67 13 34112 379 29917974
Hyponatraemia 31.13 14.67 19 34106 67183 29851170
Injection site pruritus 31.01 14.67 35 34090 5557 29912796
Prescribed overdose 30.56 14.67 43 34082 8518 29909835
Road traffic accident 30.52 14.67 63 34062 17008 29901345
Dysarthria 30.46 14.67 90 34035 30400 29887953
Headache 29.78 14.67 328 33797 181978 29736375
Injection site swelling 29.73 14.67 43 34082 8737 29909616
Gastrointestinal haemorrhage 29.39 14.67 31 34094 83415 29834938
Myocardial infarction 29.35 14.67 62 34063 125563 29792790
Incorrect route of product administration 29.34 14.67 49 34076 11266 29907087
Substance use 29.33 14.67 13 34112 445 29917908
Foetal distress syndrome 27.55 14.67 16 34109 975 29917378
Vestibular ischaemia 27.46 14.67 6 34119 14 29918339
Unresponsive to stimuli 27.37 14.67 79 34046 26340 29892013
Pancytopenia 27.35 14.67 34 34091 85018 29833335
Joint hyperextension 27.02 14.67 7 34118 41 29918312
Disturbance in attention 26.72 14.67 70 34055 22059 29896294
Renal impairment 26.71 14.67 34 34091 84150 29834203
Thermophobia 26.37 14.67 8 34117 89 29918264
Plasma cell myeloma 26.36 14.67 14 34111 53448 29864905
Breech presentation 26.11 14.67 9 34116 154 29918199
Haemorrhage 25.94 14.67 10 34115 46069 29872284
Decreased gait velocity 25.82 14.67 8 34117 96 29918257
Ear deformity acquired 25.43 14.67 5 34120 5 29918348
Accidental exposure to product 25.16 14.67 43 34082 10072 29908281
Product dose omission issue 25.14 14.67 41 34084 91590 29826763
Vestibular disorder 24.95 14.67 14 34111 799 29917554
Product administered at inappropriate site 24.70 14.67 18 34107 1617 29916736
Troponin T increased 24.67 14.67 17 34108 1397 29916956
Cerebral congestion 24.47 14.67 6 34119 27 29918326
Psoriasis 24.31 14.67 9 34116 42497 29875856
Thrombosis 24.05 14.67 9 34116 42222 29876131
Sepsis 23.92 14.67 86 34039 146309 29772044
Infection 23.27 14.67 33 34092 78041 29840312
Septic pulmonary embolism 23.11 14.67 4 34121 0 29918353
Skin irritation 22.84 14.67 26 34099 4166 29914187
Therapy naive 22.79 14.67 5 34120 12 29918341
Neutrophil count decreased 22.63 14.67 10 34115 42444 29875909
Clumsiness 22.62 14.67 16 34109 1371 29916982
Respiratory arrest 22.53 14.67 79 34046 29179 29889174
Joint swelling 22.12 14.67 13 34112 46933 29871420
Agitation neonatal 21.95 14.67 14 34111 1011 29917342
Disorientation 21.80 14.67 82 34043 31336 29887017
Application site ulcer 21.74 14.67 5 34120 16 29918337
Herpes zoster 21.55 14.67 4 34121 29939 29888414
Poisoning 21.53 14.67 43 34082 11339 29907014
Cyanosis 21.28 14.67 44 34081 11891 29906462
Urinary tract infection 21.11 14.67 32 34093 73627 29844726
Victim of crime 20.98 14.67 9 34116 284 29918069
Substance dependence 20.97 14.67 10 34115 406 29917947
Hypertension 20.68 14.67 70 34055 121284 29797069
Chronic actinic dermatitis 20.67 14.67 5 34120 21 29918332
Skull fracture 20.67 14.67 13 34112 916 29917437
Rectal haemorrhage 20.66 14.67 7 34118 34932 29883421
Acute myocardial infarction 20.58 14.67 18 34107 52921 29865432
Embolia cutis medicamentosa 20.54 14.67 8 34117 196 29918157
Hypoxic-ischaemic encephalopathy 20.50 14.67 26 34099 4661 29913692
Pulmonary congestion 20.40 14.67 44 34081 12243 29906110
Depressed level of consciousness 20.39 14.67 92 34033 38130 29880223
General physical health deterioration 20.39 14.67 53 34072 99891 29818462
Application site scab 20.18 14.67 6 34119 62 29918291
Mucosal inflammation 20.06 14.67 5 34120 30489 29887864
Hallucinations, mixed 20.02 14.67 19 34106 2464 29915889
Rheumatoid arthritis 20.00 14.67 11 34114 41186 29877167
Bronchitis 19.65 14.67 10 34115 39115 29879238
Product use in unapproved indication 19.26 14.67 34 34091 73659 29844694
Tachyphrenia 19.15 14.67 13 34112 1043 29917310
Back pain 19.01 14.67 57 34068 102539 29815814
Blood bilirubin increased 18.95 14.67 9 34116 36627 29881726
Accidental death 18.88 14.67 17 34108 2062 29916291
Pulmonary oedema 18.56 14.67 99 34026 43876 29874477
Tongue discomfort 18.50 14.67 9 34116 382 29917971
Weight increased 18.31 14.67 36 34089 74877 29843476
Piloerection 18.19 14.67 7 34118 166 29918187
Injection site bruising 17.99 14.67 31 34094 7307 29911046
Micrognathia 17.96 14.67 8 34117 277 29918076
Application site haemorrhage 17.87 14.67 9 34116 412 29917941
Pain in extremity 17.83 14.67 65 34060 110156 29808197
Diabetes mellitus 17.82 14.67 13 34112 41852 29876501
Adrenocorticotropic hormone deficiency 17.53 14.67 9 34116 429 29917924
Injection site ischaemia 17.34 14.67 3 34122 0 29918353
Application site odour 17.34 14.67 3 34122 0 29918353
Hypokalaemia 17.27 14.67 19 34106 50173 29868180
Product physical consistency issue 17.24 14.67 8 34117 305 29918048
Abdominal distension 17.21 14.67 16 34109 45693 29872660
Pain 17.13 14.67 284 33841 172357 29745996
Needle track marks 17.11 14.67 4 34121 14 29918339
Rash maculo-papular 17.05 14.67 4 34121 25414 29892939
Coordination abnormal 16.80 14.67 30 34095 7275 29911078
Product contamination 16.79 14.67 10 34115 639 29917714
Persecutory delusion 16.54 14.67 16 34109 2124 29916229
Libido decreased 16.40 14.67 23 34102 4543 29913810
Drug reaction with eosinophilia and systemic symptoms 16.34 14.67 6 34119 28482 29889871
Wrong dose 16.30 14.67 8 34117 346 29918007
Pulmonary embolism 16.27 14.67 41 34084 78094 29840259
Hyperglycaemia 16.23 14.67 10 34115 35190 29883163
Blood pressure decreased 16.00 14.67 18 34107 47057 29871296
Injection site scab 15.97 14.67 4 34121 20 29918333
Hallucination 15.89 14.67 103 34022 48956 29869397
Chest discomfort 15.89 14.67 17 34108 45463 29872890
Poisoning deliberate 15.89 14.67 26 34099 5878 29912475
Acute cardiac event 15.81 14.67 4 34121 21 29918332
Acute respiratory failure 15.59 14.67 5 34120 25845 29892508
Formication 15.51 14.67 14 34111 1703 29916650
Infantile vomiting 15.50 14.67 4 34121 23 29918330
Multiple cardiac defects 15.50 14.67 5 34120 69 29918284
Gun shot wound 15.45 14.67 12 34113 1186 29917167
Neuromuscular blockade 15.29 14.67 6 34119 150 29918203
Dermal absorption impaired 15.26 14.67 3 34122 3 29918350
Medical observation 15.26 14.67 3 34122 3 29918350
Insomnia 15.23 14.67 168 33957 93168 29825185
Haematocrit decreased 15.19 14.67 8 34117 30691 29887662
Mydriasis 15.13 14.67 26 34099 6117 29912236
Dyspnoea exertional 15.08 14.67 11 34114 35419 29882934
Breakthrough pain 14.98 14.67 9 34116 584 29917769
Transient ischaemic attack 14.98 14.67 5 34120 25195 29893158
Abdominal pain 14.89 14.67 92 34033 135562 29782791
Delirium 14.85 14.67 88 34037 40543 29877810
Palatal disorder 14.76 14.67 6 34119 165 29918188
Oropharyngeal pain 14.74 14.67 7 34118 28489 29889864
Alanine aminotransferase increased 14.68 14.67 40 34085 74236 29844117

Pharmacologic Action:

SourceCodeDescription
ATC N02AE01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Oripavine derivatives
ATC N07BC01 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
ATC N07BC51 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
DRUGS USED IN ADDICTIVE DISORDERS
Drugs used in opioid dependence
FDA MoA N0000175685 Partial Opioid Agonists
FDA EPC N0000175689 Partial Opioid Agonist
CHEBI has role CHEBI:35482 narcotic analgesics
CHEBI has role CHEBI:55322 mu opioid agonist
CHEBI has role CHEBI:59283 delta-opioid antagonists
CHEBI has role CHEBI:167165 kappa-opioid receptor antagonists
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009292 Narcotic Antagonists
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:59282 kappa-opioid receptor agonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Opioid dependence indication 75544000 DOID:2559
Severe pain indication 76948002
Chronic pain indication 82423001
Prevention of opioid abuse indication 426928008
Acute postoperative pain indication 107401000119105
Chronic Pain with Opioid Tolerance indication
Opioid withdrawal off-label use 87132004
Dependent drug abuse contraindication 6525002
Alcohol withdrawal delirium contraindication 8635005
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Chronic disease of respiratory system contraindication 17097001
Alcohol intoxication contraindication 25702006
Orthostatic hypotension contraindication 28651003
Hypercapnia contraindication 29596007
Torsades de pointes contraindication 31722008
Hypothyroidism contraindication 40930008 DOID:1459
Paralytic ileus contraindication 55525008 DOID:8442
Chronic type B viral hepatitis contraindication 61977001
Benign intracranial hypertension contraindication 68267002 DOID:11459
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Disease of liver contraindication 235856003 DOID:409
Benign prostatic hyperplasia contraindication 266569009
Lesion of brain contraindication 301766008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Hypoxia contraindication 389086002
Respiratory insufficiency contraindication 409623005
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Kyphoscoliosis with Respiratory Compromise contraindication
Pain in Opioid Naive Patients contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.97 acidic
pKa2 8.88 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Kappa-type opioid receptor GPCR ANTAGONIST Ki 9.01 WOMBAT-PK CHEMBL
Mu-type opioid receptor GPCR PARTIAL AGONIST Ki 8.29 WOMBAT-PK CHEMBL
Nociceptin receptor GPCR Ki 7.11 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.10 CHEMBL
Delta-type opioid receptor GPCR ANTAGONIST Ki 8.07 WOMBAT-PK
Mu-type opioid receptor GPCR Ki 9.40 CHEMBL
Delta-type opioid receptor GPCR Ki 9.32 CHEMBL
Mu-type opioid receptor GPCR Ki 9.89 CHEMBL
Kappa-type opioid receptor GPCR Ki 9.30 CHEMBL

External reference:

IDSource
4019644 VUID
N0000147737 NUI
D00836 KEGG_DRUG
53152-21-9 SECONDARY_CAS_RN
4018880 VANDF
4019644 VANDF
C0006405 UMLSCUI
CHEBI:3216 CHEBI
CHEMBL511142 ChEMBL_ID
CHEMBL560511 ChEMBL_ID
CHEMBL2368861 ChEMBL_ID
DB00921 DRUGBANK_ID
D002047 MESH_DESCRIPTOR_UI
3403 INN_ID
644073 PUBCHEM_CID
1670 IUPHAR_LIGAND_ID
40D3SCR4GZ UNII
1819 RXNORM
11186 MMSL
257949 MMSL
27271 MMSL
31700 MMSL
4306 MMSL
d00840 MMSL
001573 NDDF
004632 NDDF
21066009 SNOMEDCT_US
31684002 SNOMEDCT_US
387173000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0176 TABLET 2 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HCl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0177 TABLET 8 mg SUBLINGUAL ANDA 32 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0188 TABLET 2 mg SUBLINGUAL ANDA 32 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0054-0189 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3656 PATCH, EXTENDED RELEASE 5 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3657 PATCH, EXTENDED RELEASE 10 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3658 PATCH, EXTENDED RELEASE 15 ug TRANSDERMAL ANDA 31 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3659 PATCH, EXTENDED RELEASE 20 ug TRANSDERMAL ANDA 31 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9246 INJECTION 0.32 mg INTRAMUSCULAR ANDA 16 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3153 TABLET 8 mg SUBLINGUAL ANDA 31 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3154 TABLET 2 mg SUBLINGUAL ANDA 32 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0228-3155 TABLET 8 mg SUBLINGUAL ANDA 32 sections
Buprenorphine HUMAN PRESCRIPTION DRUG LABEL 1 0228-3156 TABLET 2 mg SUBLINGUAL ANDA 31 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8765 FILM 2 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8766 FILM 4 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8767 FILM 8 mg SUBLINGUAL ANDA 34 sections
Buprenorphine and Naloxone HUMAN PRESCRIPTION DRUG LABEL 2 0378-8768 FILM 12 mg SUBLINGUAL ANDA 34 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8005 TABLET 2 mg SUBLINGUAL ANDA 30 sections
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0406-8020 TABLET 8 mg SUBLINGUAL ANDA 30 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-2012 INJECTION, SOLUTION 0.30 mg INTRAMUSCULAR ANDA 31 sections
Buprenorphine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-0725 INJECTION, SOLUTION 0.32 mg INTRAMUSCULAR ANDA 21 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7009 TABLET 2 mg SUBLINGUAL ANDA 32 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7010 TABLET 8 mg SUBLINGUAL ANDA 32 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0100 SOLUTION 100 mg SUBCUTANEOUS NDA 33 sections
SUBLOCADE HUMAN PRESCRIPTION DRUG LABEL 1 12496-0300 SOLUTION 300 mg SUBCUTANEOUS NDA 33 sections
Buprenex HUMAN PRESCRIPTION DRUG LABEL 1 12496-0757 INJECTION 0.30 mg INTRAVENOUS NDA 28 sections
Suboxone HUMAN PRESCRIPTION DRUG LABEL 2 12496-1202 FILM, SOLUBLE 2 mg SUBLINGUAL NDA 31 sections
Suboxone HUMAN PRESCRIPTION DRUG LABEL 2 12496-1204 FILM, SOLUBLE 4 mg SUBLINGUAL NDA 31 sections
Suboxone HUMAN PRESCRIPTION DRUG LABEL 2 12496-1208 FILM, SOLUBLE 8 mg SUBLINGUAL NDA 31 sections
Suboxone HUMAN PRESCRIPTION DRUG LABEL 2 12496-1212 FILM, SOLUBLE 12 mg SUBLINGUAL NDA 31 sections