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

Stem definitionDrug idCAS RN
opioid receptor agonists, analgesics, fentanyl derivatives 1164 437-38-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fentanyl
  • fentanil
  • fentanyl citrate
  • effentora
  • instanyl
  • fentanyl hydrochloride
  • fentanyl HCl
A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance.
  • Molecular weight: 336.48
  • Formula: C22H28N2O
  • CLOGP: 3.62
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 23.55
  • ALOGS: -4.15
  • ROTB: 6

Drug dosage:

DoseUnitRoute
0.60 mg N
0.60 mg SL
1.20 mg TD

Approvals:

DateAgencyCompanyOrphan
Feb. 19, 1968 FDA AKORN

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
Drug abuse 10313.29 32.71 2525 15448 25422 4595597
Toxicity to various agents 9392.69 32.71 2863 15110 69177 4551842
Overdose 3245.47 32.71 1148 16825 42411 4578608
Cardio-respiratory arrest 2580.31 32.71 798 17175 19024 4601995
Accidental overdose 2375.59 32.71 633 17340 8622 4612397
Cardiac arrest 2165.19 32.71 800 17173 33207 4587812
Respiratory arrest 2042.27 32.71 610 17363 12810 4608209
Serotonin syndrome 1795.08 32.71 481 17492 6671 4614348
Death 1664.25 32.71 1178 16795 196985 4424034
Intentional product misuse 1455.50 32.71 510 17463 17983 4603036
Completed suicide 1440.64 32.71 636 17337 41809 4579210
Respiratory depression 1316.00 32.71 351 17622 4759 4616260
Incorrect route of product administration 1306.12 32.71 418 17555 11055 4609964
Somnolence 1236.67 32.71 577 17396 43083 4577936
Drug hypersensitivity 1233.21 32.71 665 17308 67735 4553284
Hypotension 1133.43 32.71 626 17347 66774 4554245
Inadequate analgesia 962.07 32.71 207 17766 1009 4620010
Unresponsive to stimuli 939.46 32.71 316 17657 9777 4611242
Drug interaction 918.88 32.71 538 17435 63970 4557049
Depressed level of consciousness 871.35 32.71 332 17641 14822 4606197
Oxygen saturation decreased 839.37 32.71 317 17656 13804 4607215
Drug withdrawal syndrome 813.44 32.71 301 17672 12371 4608648
Anaphylactic reaction 779.87 32.71 321 17652 17589 4603430
Drug ineffective 751.59 32.71 727 17246 185334 4435685
Product prescribing error 728.24 32.71 240 17733 6946 4614073
Nausea 721.74 32.71 696 17277 176637 4444382
Apnoea 674.45 32.71 188 17785 3020 4617999
Pain 671.86 32.71 508 17465 92362 4528657
Delirium 660.20 32.71 259 17714 12493 4608526
Bradycardia 648.71 32.71 302 17671 22267 4598752
Product quality issue 631.05 32.71 286 17687 19813 4601206
Wrong technique in product usage process 630.41 32.71 337 17636 33437 4587582
Miosis 624.20 32.71 173 17800 2717 4618302
Vomiting 622.89 32.71 540 17433 119159 4501860
Poisoning 615.18 32.71 202 17771 5772 4615247
Product complaint 565.10 32.71 202 17771 7492 4613527
Drug dependence 550.00 32.71 193 17780 6774 4614245
Pulmonary oedema 510.90 32.71 226 17747 14760 4606259
Post procedural complication 498.48 32.71 171 17802 5600 4615419
Hyperaesthesia 491.57 32.71 134 17839 1970 4619049
Product adhesion issue 483.76 32.71 129 17844 1736 4619283
Confusional state 483.52 32.71 324 17649 48510 4572509
Tachycardia 463.76 32.71 268 17705 30877 4590142
Agitation 461.10 32.71 245 17728 23955 4597064
Accidental death 443.31 32.71 103 17870 749 4620270
Loss of consciousness 430.02 32.71 268 17705 35414 4585605
Coma 422.60 32.71 208 17765 17311 4603708
Muscle rigidity 395.01 32.71 131 17842 3856 4617163
Withdrawal syndrome 380.64 32.71 144 17829 6270 4614749
Sedation 375.53 32.71 150 17823 7567 4613452
Constipation 358.81 32.71 255 17718 41899 4579120
Hyperhidrosis 350.99 32.71 221 17752 29696 4591323
Hypoxia 347.12 32.71 166 17807 12955 4608064
Exposure during pregnancy 321.71 32.71 217 17756 32754 4588265
Anaesthetic complication 311.94 32.71 78 17895 798 4620221
Myoclonus 305.30 32.71 116 17857 5108 4615911
Medication error 300.16 32.71 155 17818 14261 4606758
Maternal exposure during delivery 299.91 32.71 59 17914 164 4620855
Delayed recovery from anaesthesia 298.39 32.71 64 17909 305 4620714
Presbyacusis 283.96 32.71 50 17923 54 4620965
Drug diversion 280.02 32.71 66 17907 514 4620505
Mental status changes 274.85 32.71 139 17834 12237 4608782
Foetal exposure during pregnancy 273.75 32.71 172 17801 22997 4598022
Blood pressure decreased 268.70 32.71 155 17818 17745 4603274
Mental status changes postoperative 266.73 32.71 45 17928 28 4620991
Therapeutic product effect decreased 264.62 32.71 156 17817 18597 4602422
Product administration error 256.81 32.71 117 17856 8167 4612852
Hyperthermia malignant 253.14 32.71 63 17910 631 4620388
Sedation complication 251.12 32.71 56 17917 330 4620689
Respiratory rate decreased 250.14 32.71 68 17905 987 4620032
Stress cardiomyopathy 239.81 32.71 76 17897 1927 4619092
Drug use disorder 222.64 32.71 61 17912 913 4620106
Deafness neurosensory 219.14 32.71 64 17909 1220 4619799
Respiratory failure 218.38 32.71 166 17807 30160 4590859
Pleural thickening 217.86 32.71 42 17931 101 4620918
Application site rash 217.28 32.71 60 17913 926 4620093
Maternal exposure during pregnancy 207.13 32.71 129 17844 16964 4604055
Pleural fibrosis 202.78 32.71 49 17924 429 4620590
Therapeutic response unexpected 202.74 32.71 94 17879 6828 4614191
Off label use 200.81 32.71 313 17660 128800 4492219
Cyanosis 199.54 32.71 90 17883 6132 4614887
Lethargy 198.59 32.71 126 17847 17115 4603904
Drug abuser 197.29 32.71 71 17902 2676 4618343
Respiratory acidosis 196.10 32.71 62 17911 1559 4619460
Blood magnesium increased 190.64 32.71 44 17929 309 4620710
Application site pruritus 187.73 32.71 57 17916 1248 4619771
Dyspnoea 186.31 32.71 315 17658 138670 4482349
Pulseless electrical activity 186.18 32.71 64 17909 2103 4618916
Procedural hypotension 183.75 32.71 45 17928 419 4620600
Hallucination 183.50 32.71 121 17852 17547 4603472
Premature baby 180.62 32.71 98 17875 9953 4611066
Rhabdomyolysis 177.02 32.71 123 17850 19435 4601584
Disorientation 176.62 32.71 104 17869 12355 4608664
Hypoventilation 174.76 32.71 54 17919 1256 4619763
Circulatory collapse 174.43 32.71 88 17885 7697 4613322
Dizziness 171.96 32.71 254 17719 99617 4521402
Procedural complication 171.48 32.71 62 17911 2368 4618651
Bronchospasm 170.01 32.71 78 17895 5528 4615491
Substance abuse 169.28 32.71 56 17917 1632 4619387
Application site erythema 169.26 32.71 59 17914 2022 4618997
Brain injury 167.57 32.71 59 17914 2084 4618935
Osteopenia 162.06 32.71 61 17912 2613 4618406
Bradypnoea 158.34 32.71 45 17928 775 4620244
Drug screen positive 158.20 32.71 57 17916 2155 4618864
Coma scale abnormal 156.90 32.71 52 17921 1524 4619495
Seizure 155.16 32.71 171 17802 50066 4570953
Tremor 154.85 32.71 147 17826 36112 4584907
Inappropriate schedule of product administration 153.41 32.71 119 17854 22251 4598768
Pulmonary congestion 151.87 32.71 65 17908 3901 4617118
Drug tolerance 150.08 32.71 44 17929 850 4620169
Urinary retention 149.63 32.71 86 17887 9761 4611258
Epigastric discomfort 148.25 32.71 45 17928 984 4620035
Bradycardia foetal 146.55 32.71 35 17938 290 4620729
Hypermobility syndrome 146.53 32.71 28 17945 63 4620956
Clonus 146.41 32.71 46 17927 1132 4619887
Condition aggravated 142.86 32.71 176 17797 57995 4563024
Product counterfeit 141.72 32.71 33 17940 242 4620777
Insomnia 137.67 32.71 153 17820 45192 4575827
Horner's syndrome 137.19 32.71 30 17943 159 4620860
Intentional product use issue 134.98 32.71 72 17901 7063 4613956
Intentional overdose 134.67 32.71 109 17864 21657 4599362
Abdominal pain 132.16 32.71 172 17801 59852 4561167
Application site vesicles 131.63 32.71 37 17936 611 4620408
Musculoskeletal stiffness 130.56 32.71 101 17872 18801 4602218
Incorrect dose administered 130.46 32.71 102 17871 19283 4601736
Application site irritation 130.40 32.71 38 17935 718 4620301
Heart rate increased 130.09 32.71 100 17873 18442 4602577
Renal impairment 126.20 32.71 112 17861 25226 4595793
Pruritus 123.92 32.71 184 17789 72388 4548631
Accidental exposure to product by child 123.50 32.71 44 17929 1609 4619410
Fall 122.13 32.71 190 17783 77856 4543163
Narcotic bowel syndrome 121.54 32.71 23 17950 48 4620971
Hypoxic-ischaemic encephalopathy 120.58 32.71 44 17929 1725 4619294
Ventricular fibrillation 118.58 32.71 60 17913 5277 4615742
Product use in unapproved indication 118.54 32.71 108 17865 25165 4595854
Multiple organ dysfunction syndrome 118.30 32.71 95 17878 18661 4602358
Brain oedema 118.28 32.71 58 17915 4769 4616250
Fatigue 117.88 32.71 267 17706 145299 4475720
General physical health deterioration 115.89 32.71 113 17860 28665 4592354
Hypercapnia 113.74 32.71 38 17935 1142 4619877
Cyst 113.71 32.71 46 17927 2392 4618627
Asthenia 113.45 32.71 194 17779 85969 4535050
Respiratory distress 112.64 32.71 75 17898 11041 4609978
Dyskinesia 112.30 32.71 70 17903 9205 4611814
Hypertension 110.90 32.71 145 17828 50653 4570366
Skin lesion 109.67 32.71 64 17909 7469 4613550
Therapeutic product effect increased 109.55 32.71 31 17942 525 4620494
Blood potassium increased 109.47 32.71 56 17917 5039 4615980
Cardiomegaly 107.80 32.71 55 17918 4922 4616097
Sleep apnoea syndrome 106.95 32.71 53 17920 4458 4616561
Potentiating drug interaction 104.30 32.71 38 17935 1483 4619536
Sinus tachycardia 104.29 32.71 58 17915 6176 4614843
Amnestic disorder 104.04 32.71 24 17949 168 4620851
Anxiety 103.18 32.71 136 17837 47875 4573144
Dry eye 102.61 32.71 55 17918 5446 4615573
Pneumonia aspiration 102.01 32.71 67 17906 9639 4611380
Respiratory disorder 101.78 32.71 62 17911 7826 4613193
Exposure via ingestion 101.33 32.71 37 17936 1453 4619566
Counterfeit product administered 100.67 32.71 21 17952 85 4620934
Drug withdrawal syndrome neonatal 99.07 32.71 38 17935 1714 4619305
Deformity 98.31 32.71 30 17943 668 4620351
Breakthrough pain 97.28 32.71 26 17947 352 4620667
Product administered at inappropriate site 96.77 32.71 35 17938 1337 4619682
Hypersensitivity 95.45 32.71 117 17856 38304 4582715
Haemodynamic instability 95.42 32.71 42 17931 2697 4618322
Ventricular tachycardia 95.32 32.71 58 17915 7306 4613713
Back pain 94.62 32.71 134 17839 50465 4570554
Hypothermia 94.17 32.71 48 17925 4286 4616733
Accidental exposure to product 93.99 32.71 73 17900 13659 4607360
Foetal heart rate deceleration abnormality 93.57 32.71 25 17948 338 4620681
Leukoencephalopathy 93.20 32.71 37 17936 1831 4619188
Premature delivery 92.84 32.71 47 17926 4137 4616882
Hypopnoea 92.62 32.71 29 17944 705 4620314
Cardiogenic shock 92.43 32.71 51 17922 5347 4615672
Anaphylactic shock 91.85 32.71 58 17915 7799 4613220
Altered state of consciousness 91.09 32.71 58 17915 7913 4613106
Status epilepticus 90.83 32.71 49 17924 4914 4616105
Blood creatinine increased 90.72 32.71 96 17877 26804 4594215
Carcinoid crisis 90.46 32.71 18 17955 54 4620965
Bone cyst 90.11 32.71 23 17950 257 4620762
Self-medication 89.25 32.71 33 17940 1343 4619676
Upper airway obstruction 87.06 32.71 23 17950 297 4620722
Malignant neoplasm progression 86.38 32.71 97 17876 28939 4592080
Application site reaction 86.36 32.71 26 17947 552 4620467
Sleep disorder 86.18 32.71 64 17909 11199 4609820
Encephalopathy 86.09 32.71 61 17912 9926 4611093
Osteoarthritis 85.90 32.71 60 17913 9544 4611475
Restlessness 84.33 32.71 59 17914 9410 4611609
Anaesthetic complication neurological 84.12 32.71 21 17952 213 4620806
Gait disturbance 83.70 32.71 107 17866 36533 4584486
Acute kidney injury 82.84 32.71 151 17822 70280 4550739
Faecaloma 81.95 32.71 33 17940 1695 4619324
Laryngospasm 81.70 32.71 30 17943 1197 4619822
Labile blood pressure 81.30 32.71 23 17950 389 4620630
Device failure 80.87 32.71 38 17935 2841 4618178
Generalised tonic-clonic seizure 80.85 32.71 59 17914 10051 4610968
Atrial fibrillation 80.68 32.71 97 17876 31118 4589901
Heart rate decreased 80.41 32.71 51 17922 6909 4614110
Urticaria 80.25 32.71 109 17864 39464 4581555
Muscular weakness 79.50 32.71 89 17884 26461 4594558
Pyrexia 79.42 32.71 190 17783 106954 4514065
Brain death 79.32 32.71 29 17944 1143 4619876
Neuroleptic malignant syndrome 78.86 32.71 47 17926 5700 4615319
Blood pressure increased 78.53 32.71 93 17880 29367 4591652
Metabolic acidosis 78.40 32.71 63 17910 12377 4608642
Feeling abnormal 77.99 32.71 103 17870 36302 4584717
Nystagmus 77.71 32.71 35 17938 2373 4618646
Ankylosing spondylitis 77.19 32.71 31 17942 1581 4619438
Stridor 76.89 32.71 29 17944 1248 4619771
Osteosclerosis 76.59 32.71 23 17950 484 4620535
Pulse absent 76.37 32.71 33 17940 2026 4618993
Trigemino-cardiac reflex 75.92 32.71 13 17960 10 4621009
Neurotoxicity 75.73 32.71 45 17928 5428 4615591
Kounis syndrome 74.86 32.71 25 17948 750 4620269
Product tampering 73.45 32.71 18 17955 168 4620851
Suicide attempt 73.16 32.71 76 17897 20766 4600253
Foetal exposure during delivery 72.42 32.71 18 17955 179 4620840
Aspiration 72.37 32.71 38 17935 3607 4617412
Toxicologic test abnormal 72.20 32.71 20 17953 312 4620707
Renal failure 72.11 32.71 106 17867 41263 4579756
Gastrointestinal disorder 72.10 32.71 67 17906 15994 4605025
Areflexia 71.26 32.71 27 17946 1177 4619842
Compartment syndrome 70.60 32.71 26 17947 1046 4619973
Anticholinergic syndrome 70.49 32.71 22 17951 529 4620490
Malaise 70.17 32.71 163 17810 89994 4531025
Hallucination, visual 70.07 32.71 44 17929 5858 4615161
Accidental poisoning 70.01 32.71 20 17953 351 4620668
Electrocardiogram ST segment depression 68.41 32.71 26 17947 1143 4619876
Chills 67.08 32.71 85 17888 28754 4592265
Hyperreflexia 67.00 32.71 28 17945 1582 4619437
Pneumonia 66.36 32.71 173 17800 102642 4518377
Muscle spasms 66.32 32.71 94 17879 35396 4585623
Application site burn 65.44 32.71 19 17954 354 4620665
Mydriasis 65.43 32.71 36 17937 3752 4617267
Erythema 65.35 32.71 102 17871 41838 4579181
Drug intolerance 65.27 32.71 73 17900 21673 4599346
Vasoplegia syndrome 64.46 32.71 19 17954 374 4620645
Thermophobia 64.10 32.71 10 17963 0 4621019
Obstructive airways disorder 62.74 32.71 31 17942 2589 4618430
Drug level increased 62.67 32.71 42 17931 6244 4614775
Tryptase increased 62.51 32.71 15 17958 127 4620892
Rash 61.56 32.71 174 17799 108214 4512805
Decreased appetite 61.38 32.71 117 17856 56280 4564739
Confusion postoperative 60.31 32.71 12 17961 36 4620983
Head titubation 59.95 32.71 17 17956 290 4620729
Allodynia 59.11 32.71 16 17957 228 4620791
Low birth weight baby 58.83 32.71 30 17943 2680 4618339
Aggression 58.59 32.71 56 17917 13843 4607176
Caesarean section 58.00 32.71 37 17936 5061 4615958
Hypertonia 57.78 32.71 30 17943 2782 4618237
Treatment failure 57.75 32.71 56 17917 14091 4606928
Hyperthermia 57.66 32.71 32 17941 3392 4617627
Disturbance in attention 57.13 32.71 49 17924 10532 4610487
Dehydration 56.58 32.71 96 17877 42194 4578825
Adverse drug reaction 55.81 32.71 56 17917 14683 4606336
Exostosis 55.69 32.71 26 17947 1915 4619104
Weight decreased 55.62 32.71 110 17863 54354 4566665
Cognitive disorder 55.50 32.71 48 17925 10433 4610586
Dermatitis contact 55.11 32.71 27 17946 2214 4618805
Atrioventricular block complete 54.87 32.71 30 17943 3088 4617931
Blood creatine phosphokinase increased 54.68 32.71 56 17917 15043 4605976
Tachypnoea 54.28 32.71 35 17938 4876 4616143
Sopor 54.26 32.71 39 17934 6487 4614532
Product use issue 53.85 32.71 71 17902 24965 4596054
Acute respiratory distress syndrome 53.71 32.71 41 17932 7472 4613547
Hypersomnia 53.23 32.71 33 17940 4294 4616725
White blood cell count abnormal 52.24 32.71 22 17951 1267 4619752
Infusion site mass 52.15 32.71 13 17960 131 4620888
Increased bronchial secretion 52.12 32.71 17 17956 473 4620546
Application site pain 51.80 32.71 27 17946 2524 4618495
Syncope 51.70 32.71 81 17892 33314 4587705
Therapeutic response decreased 51.25 32.71 53 17920 14398 4606621
Irritability 51.22 32.71 51 17922 13248 4607771
Airway peak pressure increased 51.17 32.71 11 17962 53 4620966
Pneumothorax 51.11 32.71 35 17938 5390 4615629
Feeling cold 51.08 32.71 34 17939 4997 4616022
Aspartate aminotransferase increased 51.00 32.71 69 17904 24869 4596150
Infection 50.95 32.71 84 17889 36058 4584961
Wheezing 50.89 32.71 47 17926 11127 4609892
Dependence 50.79 32.71 19 17954 799 4620220
Postoperative delirium 50.77 32.71 10 17963 28 4620991
Myocardial ischaemia 50.75 32.71 36 17937 5866 4615153
Dysarthria 50.68 32.71 49 17924 12283 4608736
Depression 50.67 32.71 98 17875 47635 4573384
Poor quality product administered 50.50 32.71 23 17950 1600 4619419
Skin reaction 49.99 32.71 30 17943 3683 4617336
Conversion disorder 49.80 32.71 17 17956 546 4620473
Pupil fixed 49.63 32.71 19 17954 852 4620167
Neuralgia 49.30 32.71 32 17941 4508 4616511
Visceral congestion 49.12 32.71 13 17960 169 4620850
Postoperative ileus 49.09 32.71 14 17959 244 4620775
Diarrhoea 48.85 32.71 200 17773 149985 4471034
Wound 48.84 32.71 32 17941 4580 4616439
Autonomic nervous system imbalance 48.46 32.71 19 17954 909 4620110
Toxic leukoencephalopathy 48.37 32.71 13 17960 180 4620839
Hypoaesthesia 47.91 32.71 76 17897 31589 4589430
Secondary adrenocortical insufficiency 47.77 32.71 15 17958 368 4620651
Prescription drug used without a prescription 47.41 32.71 16 17957 496 4620523
Product contamination 47.35 32.71 16 17957 498 4620521
Electrocardiogram ST segment elevation 47.33 32.71 22 17951 1604 4619415
Hyperkalaemia 47.23 32.71 53 17920 15784 4605235
Therapy naive 47.17 32.71 9 17964 20 4620999
Headache 47.16 32.71 172 17801 122201 4498818
Eye movement disorder 47.00 32.71 24 17949 2150 4618869
Lymphatic fistula 46.87 32.71 9 17964 21 4620998
Therapy non-responder 46.85 32.71 53 17920 15924 4605095
Airway complication of anaesthesia 46.62 32.71 11 17962 86 4620933
Femoral hernia incarcerated 46.57 32.71 9 17964 22 4620997
Mobility decreased 46.05 32.71 48 17925 13157 4607862
Abnormal behaviour 46.00 32.71 46 17927 12010 4609009
Euphoric mood 45.87 32.71 23 17950 1982 4619037
Contraindicated product administered 45.63 32.71 32 17941 5119 4615900
Acute chest syndrome 45.27 32.71 12 17961 157 4620862
Neuromuscular blockade 45.24 32.71 11 17962 99 4620920
Atelectasis 44.93 32.71 29 17944 4046 4616973
Ventricular extrasystoles 44.60 32.71 29 17944 4097 4616922
Dry mouth 44.58 32.71 47 17926 13054 4607965
Type I hypersensitivity 44.19 32.71 18 17955 952 4620067
Blood urea increased 44.17 32.71 39 17934 8711 4612308
Arteriosclerosis 44.02 32.71 27 17946 3447 4617572
Product substitution issue 44.00 32.71 40 17933 9278 4611741
Myocardial infarction 43.66 32.71 94 17879 49282 4571737
Maternal drugs affecting foetus 43.19 32.71 28 17945 3937 4617082
Sensory disturbance 43.00 32.71 29 17944 4356 4616663
Alanine aminotransferase increased 42.78 32.71 68 17905 28305 4592714
Memory impairment 42.55 32.71 57 17916 20346 4600673
Opiates positive 42.53 32.71 11 17962 130 4620889
Myotonia 42.40 32.71 10 17963 78 4620941
Acute postoperative sialadenitis 42.37 32.71 7 17966 3 4621016
Impaired gastric emptying 42.20 32.71 20 17953 1524 4619495
Acidosis 41.96 32.71 26 17947 3380 4617639
Alcohol poisoning 41.44 32.71 17 17956 916 4620103
Vertigo 41.13 32.71 48 17925 14908 4606111
Apnoeic attack 41.11 32.71 12 17961 228 4620791
Dystonia 41.07 32.71 29 17944 4689 4616330
Blood pressure systolic increased 41.07 32.71 28 17945 4280 4616739
Discomfort 40.11 32.71 36 17937 8214 4612805
Tachyarrhythmia 39.55 32.71 18 17955 1250 4619769
Spinal cord oedema 39.48 32.71 10 17963 108 4620911
Procedural pain 38.99 32.71 22 17951 2407 4618612
Treatment noncompliance 38.89 32.71 42 17931 11985 4609034
Adrenocorticotropic hormone deficiency 38.75 32.71 10 17963 117 4620902
Neuromuscular block prolonged 38.66 32.71 11 17962 190 4620829
Amnesia 38.12 32.71 43 17930 12878 4608141
Therapeutic product effect prolonged 37.83 32.71 11 17962 206 4620813
Suspected counterfeit product 37.82 32.71 12 17961 305 4620714
Delusion 37.07 32.71 27 17946 4583 4616436
Sensory loss 36.67 32.71 20 17953 2048 4618971
Paralysis 36.63 32.71 24 17949 3435 4617584
Adverse event 36.54 32.71 47 17926 16125 4604894
Application site dermatitis 36.53 32.71 10 17963 149 4620870
Left ventricular dysfunction 36.49 32.71 22 17951 2723 4618296
Perfume sensitivity 36.44 32.71 9 17964 87 4620932
Pancreatic steatosis 36.44 32.71 9 17964 87 4620932
Device infusion issue 35.71 32.71 12 17961 367 4620652
Abdominal distension 35.60 32.71 49 17924 17940 4603079
Mastocytosis 35.47 32.71 9 17964 98 4620921
Hypogonadism 35.40 32.71 12 17961 377 4620642
Hospitalisation 35.34 32.71 66 17907 31239 4589780
Paraplegia 34.90 32.71 16 17957 1130 4619889
Ventricular hypokinesia 34.72 32.71 17 17956 1392 4619627
Migraine 34.41 32.71 42 17931 13667 4607352
Stupor 34.28 32.71 17 17956 1431 4619588
Drug dose titration not performed 34.21 32.71 11 17962 292 4620727
Neonatal respiratory distress syndrome 34.13 32.71 18 17955 1723 4619296
Postmortem blood drug level increased 34.08 32.71 9 17964 116 4620903
Anaesthetic complication pulmonary 34.03 32.71 7 17966 26 4620993
Screaming 34.01 32.71 16 17957 1199 4619820
Incorrect drug administration rate 33.90 32.71 14 17959 767 4620252
Sinus bradycardia 33.90 32.71 25 17948 4324 4616695
Anaesthetic complication cardiac 33.82 32.71 7 17966 27 4620992
Sweat gland disorder 33.80 32.71 9 17964 120 4620899
Supraventricular tachycardia 33.66 32.71 24 17949 3941 4617078
Spinal anaesthesia 33.62 32.71 7 17966 28 4620991
Labelled drug-drug interaction medication error 33.47 32.71 22 17951 3166 4617853
Wound infection pseudomonas 33.33 32.71 9 17964 127 4620892
Restless legs syndrome 33.31 32.71 23 17950 3588 4617431
Product administered to patient of inappropriate age 33.30 32.71 19 17954 2123 4618896
Device leakage 33.15 32.71 18 17955 1827 4619192
Blood pressure systolic decreased 33.04 32.71 17 17956 1547 4619472
Uterine hypertonus 33.00 32.71 8 17965 71 4620948
Hypopituitarism 32.98 32.71 12 17961 466 4620553
Feeling hot 32.90 32.71 36 17937 10425 4610594

Pharmacologic Action:

SourceCodeDescription
ATC N01AH01 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N01AH51 NERVOUS SYSTEM
ANESTHETICS
ANESTHETICS, GENERAL
Opioid anesthetics
ATC N02AB03 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Phenylpiperidine derivatives
MeSH PA D000759 Adjuvants, Anesthesia
FDA MoA N0000175684 Full Opioid Agonists
FDA EPC N0000175690 Opioid Agonist
MeSH PA D000700 Analgesics
MeSH PA D000701 Analgesics, Opioid
MeSH PA D000777 Anesthetics
MeSH PA D018686 Anesthetics, Intravenous
CHEBI has role CHEBI:38877 intravenous anaesthetic
CHEBI has role CHEBI:38867 anaesthetic
CHEBI has role CHEBI:60809 adjuvant
CHEBI has role CHEBI:60807 anaesthesia adjuvant
CHEBI has role CHEBI:35482 opioid analgesic
CHEBI has role CHEBI:55322 mu-opioid receptor agonist
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D009294 Narcotics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pain indication 22253000
General anesthesia indication 50697003
Local anesthesia indication 386761002
Acute postoperative pain indication 107401000119105
Breakthrough Pain in Opioid Tolerant Patients indication
Chronic Pain with Opioid Tolerance indication
Regional Anesthesia for Surgery indication
Regional Anesthesia for Postoperative Pain indication
Anesthesia for cesarean section off-label use 4847005
Severe pain off-label use 76948002
Conscious sedation off-label use 314271007
Sedation in Intubated Patients off-label use
Regional Anesthesia for Labor Pain off-label use
Alcoholism contraindication 7200002
Cardiomegaly contraindication 8186001
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Chronic disease of respiratory system contraindication 17097001
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Migraine contraindication 37796009 DOID:6364
Hypertensive disorder contraindication 38341003 DOID:10763
Hypokalemia contraindication 43339004
Decreased cardiac function contraindication 43650005
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Paralytic ileus contraindication 55525008 DOID:8442
Hepatic failure contraindication 59927004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Extrapyramidal disease contraindication 76349003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Cor pulmonale contraindication 83291003 DOID:8515
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of biliary tract contraindication 105997008 DOID:9741
Prolonged QT interval contraindication 111975006
Procedure on urinary system contraindication 118677009
Hypomagnesemia contraindication 190855004
Asthma contraindication 195967001 DOID:2841
Acute pancreatitis contraindication 197456007 DOID:2913
Headache disorder contraindication 230461009
Disease of liver contraindication 235856003 DOID:409
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Lesion of brain contraindication 301766008
Pheochromocytoma contraindication 302835009
Deficiency of cholinesterase contraindication 360607009
Central nervous system depression contraindication 418072004
Congenital long QT syndrome contraindication 442917000
Acute exacerbation of asthma contraindication 708038006
Pain in Opioid Naive Patients contraindication
Headache Pain especially in Patients who are not Opiate Tolerant contraindication
Refractory Extrinsic Asthma contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.62 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 1.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 7579019 Jan. 22, 2020 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 6881208 April 19, 2022 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 0.1MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 RX SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 RX SPRAY, METERED NASAL 8889176 Jan. 16, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.1MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 RX SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE LAZANDA BTCP PHARMA N022569 June 30, 2011 RX SPRAY, METERED NASAL 8216604 Oct. 3, 2024 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8835460 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9289387 Jan. 25, 2027 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 9642797 Jan. 25, 2027 TREATMENT OF PAIN
EQ 0.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.4MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.6MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 0.8MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
EQ 1.2MG BASE ONSOLIS BDSI N022266 July 16, 2009 DISCN FILM BUCCAL 9597288 July 23, 2027 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
0.1MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.2MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.4MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.6MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
0.8MG SUBSYS BTCP PHARMA N202788 Jan. 4, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.2MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
1.6MG SUBSYS BTCP PHARMA N202788 Aug. 30, 2012 RX SPRAY SUBLINGUAL 8486973 April 27, 2030 TREATMENT OF PAIN
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 9364656 Sept. 30, 2031 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8781571 March 31, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8428708 May 21, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
EQ 40MCG BASE/ACTIVATION IONSYS THE MEDICINES CO N021338 May 22, 2006 DISCN SYSTEM IONTOPHORESIS, TRANSDERMAL 8428709 June 11, 2032 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST EC50 9.00 WOMBAT-PK CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Delta-type opioid receptor GPCR Ki 6.17 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.74 CHEMBL
Monoamine oxidase Enzyme Ki 5.26 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.71 CHEMBL
Delta-type opioid receptor GPCR IC50 8.03 CHEMBL
Mu-type opioid receptor GPCR Ki 8.07 CHEMBL
Histamine H1 receptor GPCR IC50 4.70 CHEMBL
Opioid receptor GPCR Ki 8.67 CHEMBL
Delta-type opioid receptor GPCR Ki 6.40 CHEMBL
Mu-type opioid receptor GPCR Ki 8.82 CHEMBL
Mu-type opioid receptor GPCR Ki 8.23 CHEMBL

External reference:

IDSource
D005283 MESH_DESCRIPTOR_UI
4018745 VUID
N0000147049 NUI
C0015846 UMLSCUI
D00320 KEGG_DRUG
59H156XY46 UNII
1443-54-5 SECONDARY_CAS_RN
40648001 SNOMEDCT_US
4337 RXNORM
373492002 SNOMEDCT_US
4721 MMSL
4018745 VANDF
003571 NDDF
64408 MMSL
d00233 MMSL
CHEMBL596 ChEMBL_ID
CHEMBL688 ChEMBL_ID
DB00813 DRUGBANK_ID
1608 INN_ID
CHEBI:119915 CHEBI
3345 PUBCHEM_CID
CHEMBL1201159 ChEMBL_ID
1626 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7865 LOZENGE 200 ug ORAL NDA AUTHORIZED GENERIC 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7866 LOZENGE 400 ug ORAL NDA AUTHORIZED GENERIC 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7867 LOZENGE 600 ug ORAL NDA AUTHORIZED GENERIC 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7868 LOZENGE 800 ug ORAL NDA AUTHORIZED GENERIC 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7869 LOZENGE 1200 ug ORAL NDA AUTHORIZED GENERIC 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7870 LOZENGE 1600 ug ORAL NDA AUTHORIZED GENERIC 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9119 PATCH 12 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9121 PATCH 25 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9122 PATCH 50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9123 PATCH 75 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9124 PATCH 100 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9125 PATCH 37.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9126 PATCH 62.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL HUMAN PRESCRIPTION DRUG LABEL 1 0378-9127 PATCH 87.50 ug TRANSDERMAL ANDA 20 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9000 PATCH, EXTENDED RELEASE 100 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9012 PATCH, EXTENDED RELEASE 12.50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9025 PATCH, EXTENDED RELEASE 25 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9037 PATCH, EXTENDED RELEASE 37.50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9050 PATCH, EXTENDED RELEASE 50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9062 PATCH, EXTENDED RELEASE 62.50 ug TRANSDERMAL ANDA 21 sections
FENTANYL TRANSDERMAL HUMAN PRESCRIPTION DRUG LABEL 1 0406-9075 PATCH, EXTENDED RELEASE 75 ug TRANSDERMAL ANDA 21 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9202 LOZENGE 200 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9204 LOZENGE 400 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9206 LOZENGE 600 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9208 LOZENGE 800 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9212 LOZENGE 1200 ug TRANSMUCOSAL ANDA 20 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0406-9216 LOZENGE 1600 ug TRANSMUCOSAL ANDA 20 sections
Fentanyl Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1276 INJECTION, SOLUTION 50 ug INTRAMUSCULAR ANDA 19 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0409-9093 INJECTION, SOLUTION 50 ug INTRAVENOUS NDA 19 sections
FENTANYL CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0409-9094 INJECTION, SOLUTION 50 ug INTRAVENOUS NDA 19 sections